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The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00279201
First received: December 15, 2005
Last updated: January 24, 2011
Last verified: January 2011
History of Changes
  Purpose

This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin glargine
Drug: Lispro Low Mix
Drug: Lispro Mid Mix
Drug: Lispro
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
  • MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) [ Time Frame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years) ] [ Designated as safety issue: No ]
    HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%

  • ADDENDUM: 24-Week Endpoint HbA1c [ Time Frame: Endpoint (Addendum) (24 weeks: Week 48) ] [ Designated as safety issue: No ]
    HbA1c at 24-week endpoint in Intensification Addendum of the trial.


Secondary Outcome Measures:
  • INITIATION: Change in HbA1c From Baseline to 24 Weeks [ Time Frame: Baseline (Initiation) to Endpoint (LOCF, Week 24) ] [ Designated as safety issue: No ]
  • INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
  • INITIATION: HbA1c [ Time Frame: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF) ] [ Designated as safety issue: No ]
  • INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions [ Time Frame: Endpoint (LOCF) (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.

  • INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG) [ Time Frame: Baseline (Initiation), Endpoint (Week 24) ] [ Designated as safety issue: No ]
  • INITIATION: Incremental Change From Baseline in Body Weight [ Time Frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) ] [ Designated as safety issue: Yes ]
  • INITIATION: Body Weight [ Time Frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) ] [ Designated as safety issue: Yes ]
  • INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes [ Time Frame: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]). ] [ Designated as safety issue: Yes ]
    Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • INITIATION: Rate of Self-reported Hypoglycemic Episodes [ Time Frame: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) ] [ Designated as safety issue: Yes ]
    Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • INITIATION: Insulin Dose [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF) ] [ Designated as safety issue: No ]
  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline [ Time Frame: Endpoint (Initiation: Week 24) ] [ Designated as safety issue: No ]
    Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).

  • MAINTENANCE: HbA1c at Specified Visits and Endpoint [ Time Frame: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years) ] [ Designated as safety issue: No ]
  • MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions [ Time Frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.

  • MAINTENANCE: Rate of Increase in HbA1c [ Time Frame: Endpoint (LOCF) (Maintenance: up to 2.5 years) ] [ Designated as safety issue: No ]
    Rate of increase: HbA1c change/time period (month).

  • MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% [ Time Frame: Endpoint (LOCF) (Maintenance: up to 2.5 years) ] [ Designated as safety issue: No ]
  • MAINTENANCE: Incremental Change From Baseline in Body Weight [ Time Frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: Yes ]
  • MAINTENANCE: Body Weight [ Time Frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: Yes ]
  • MAINTENANCE: Insulin Dose [ Time Frame: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
  • MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0) ] [ Designated as safety issue: Yes ]
    Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) ] [ Designated as safety issue: Yes ]
    Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol [ Time Frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) ] [ Designated as safety issue: No ]
  • MAINTENANCE: Change From Baseline to Endpoint in HbA1c [ Time Frame: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose [ Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years) ] [ Designated as safety issue: No ]
    Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.

  • ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint [ Time Frame: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48]) ] [ Designated as safety issue: No ]
  • ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% [ Time Frame: Endpoint (Addendum: 24 weeks [Week 48]) ] [ Designated as safety issue: No ]
  • ADDENDUM: 7-point SMPG Profiles [ Time Frame: Endpoint (Addendum: 24 weeks [Week 48]) ] [ Designated as safety issue: No ]
    Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.

  • ADDENDUM: Incremental Change From Baseline in Body Weight [ Time Frame: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF) ] [ Designated as safety issue: Yes ]
  • ADDENDUM: Body Weight [ Time Frame: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) ] [ Designated as safety issue: Yes ]
  • ADDENDUM: Insulin Dose [ Time Frame: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) ] [ Designated as safety issue: No ]
  • ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes [ Time Frame: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) ] [ Designated as safety issue: Yes ]
    Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • ADDENDUM: Rate of Self-reported Hypoglycemic Episodes [ Time Frame: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase ] [ Designated as safety issue: Yes ]
    Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.

  • ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 [ Time Frame: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48) ] [ Designated as safety issue: No ]
  • ADDENDUM: HbA1c at Specified Visits and Endpoint [ Time Frame: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48) ] [ Designated as safety issue: No ]

Enrollment: 2091
Study Start Date: December 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin glargine
Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
 Drug: Insulin glargine
Subcutaneous injection daily
Other Name: Lantus
Experimental: Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
 Drug: Lispro Low Mix
Subcutaneous injection twice daily.
Other Name: Humalog Mix 75/25
Experimental: Lispro Mid Mix prior Lispro Low Mix addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
 Drug: Lispro Mid Mix
Lispro Mid Mix subcutaneous injection 3 times daily.
Other Name: Humalog Mix 50/50
Experimental: Lispro Low Mix prior Glargine addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase
 Drug: Lispro Low Mix
Subcutaneous injection twice daily.
Other Name: Humalog Mix 75/25
Active Comparator: Basal bolus prior Lispro Low Mix addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
 Drug: Insulin glargine
Subcutaneous injection daily
Other Name: Lantus
Drug: Lispro
Lispro subcutaneous injection 3 times daily.
Other Name: Humalog
Active Comparator: Basal bolus prior Glargine addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
 Drug: Insulin glargine
Subcutaneous injection daily
Other Name: Lantus
Drug: Lispro
Lispro subcutaneous injection 3 times daily.
Other Name: Humalog

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have type 2 diabetes.
  • Must be at least 30 and less than 80 years of age at the time of Visit 1.
  • Must be on at least two oral antidiabetes medications for at least 90 days.
  • Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion Criteria:

  • Must not have used insulin on a regular basis in the last 12 months.
  • Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
  • Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
  • Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
  • Must not be pregnant or intend to get pregnant during course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279201

  Show 199 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00279201     History of Changes
Other Study ID Numbers: 10455, F3Z-US-IOOV
Study First Received: December 15, 2005
Results First Received: November 11, 2010
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Australia: Department of Health and Ageing Therapeutic Goods Administration
Romania: National Medicines Agency
Canada: Health Canada
Greece: National Organization of Medicines
Spain: Spanish Agency of Medicines
Brazil: National Health Surveillance Agency
India: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Eli Lilly and Company:
diabetes
type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013