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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00560417
First received: November 15, 2007
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  Purpose

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin Lispro Protamine Suspension
Drug: Insulin Glargine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.


Secondary Outcome Measures:
  • Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [ Time Frame: 24 weeks, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

  • Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) [ Time Frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
    Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

  • Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% [ Time Frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
  • 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
    SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.

  • Glycemic Variability at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]
    Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.

  • Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: Yes ]
    Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.

  • Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: Yes ]
    Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.

  • Actual Body Weight at Baseline and Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Weight at Endpoint (LOCF) [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Total Daily Insulin Dose at Endpoint (LOCF) [ Time Frame: Endpoint (LOCF) up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 339
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ILPS
Insulin Lispro Protamine Suspension (ILPS)
 Drug: Insulin Lispro Protamine Suspension
Administered subcutaneously once a day at bedtime
Other Name: LY275585[P]
Active Comparator: Glargine
Insulin Glargine
 Drug: Insulin Glargine
Administered subcutaneously once a day at bedtime
Other Name: Lantus

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have type 2 diabetes
  • Must be at least 18 years of age and less than 75 years of age
  • Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
  • Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
  • Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

  • Must not have used insulin on a regular basis during the past 2 years
  • Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
  • Must not have had more than one episode of severe hypoglycemia in the past 6 months
  • Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
  • Must not be pregnant or intend to get pregnant during the course of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560417

  Show 52 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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00560417     History of Changes
Other Study ID Numbers: 11647, F3Z-US-IOPB
Study First Received: November 15, 2007
Results First Received: November 12, 2010
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Insulin LISPRO
Glargine
Insulin
Hypoglycemic Agents
 Insulin, Long-Acting
Protamines
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013