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Insulin Glargine "All to Target" Trial

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ClinicalTrials.gov Identifier: NCT00384085
Recruitment Status : Completed
First Posted : October 4, 2006
Results First Posted : April 26, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

The primary objectives were:

  • To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60
  • To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glulisine Drug: Insulin Glargine Drug: Premixed Insulin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: All to Target Trial Lantus® (Insulin Glargine) With Stepwise Addition of APIDRA® (Insulin Glulisine) or Lantus With One Injection of Apidra vs a Twice-Daily Premixed Insulin Regimen (Novolog® Mix 70/30) in Adult Subjects With Type 2 Diabetes Failing Dual or Triple Therapy With Oral Agents: a 64-week, Multi-center, Randomized, Parallel, Open-label Clinical Study.
Study Start Date : May 2006
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lantus/Apidra-3
Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Drug: Insulin Glargine
Subcutaneous injection once-a-day
Other Name: Lantus
Drug: Insulin Glulisine
Subcutaneous injection up to 3 injections per day.
Other Name: Apidra
Experimental: Lantus/Apidra-1
Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Drug: Insulin Glulisine
Subcutaneous injection up to 1 injection per day
Other Name: Apidra
Drug: Insulin Glargine
Subcutaneous injection once-a-day
Other Name: Lantus
Experimental: Novolog Mix 70/30
Premixed insulin (Novolog® Mix 70/30) added to oral agents.
Drug: Premixed Insulin
Subcutaneous injection twice-a-day.
Other Name: Novolog Mix 70/30


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) [ Time Frame: At week 60 ]
    Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.

  2. Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population [ Time Frame: At week 60 ]
    Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.

  3. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis) [ Time Frame: At week 60 ]
    Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.


Secondary Outcome Measures :
  1. Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30) [ Time Frame: From baseline to week 60 ]
    Absolute Change in HbA1c from Baseline to Week 60.

  2. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30) [ Time Frame: At week 60 ]
    Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders.

  3. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl [ Time Frame: At week 60 ]

    Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.

    A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms.


  4. Adjusted Incidence Rate of Hypoglycemia [ Time Frame: Week 60 ]

    Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.

    A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.

    A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.

    Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.

    An event is included if the HE start date is within the treatment period.


  5. Adjusted Hypoglycemic Event Rates (Event/Patient-year) [ Time Frame: Week 60 ]

    Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.

    An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug).



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Male or female patients
  • 30 to 80 years of age
  • Body Mass Index <45 kg/m2
  • With Type 2 diabetes mellitus for at least 2 years
  • With an HbA1c level at screening of >7.5% and >7.0% at randomization
  • On stable dual or triple oral therapy for at least 3 months
  • Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG
  • Females of child-bearing potentially were required to be willing and able to use adequate contraception
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384085


Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Affairs Sanofi
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00384085     History of Changes
Other Study ID Numbers: HMR1964A_3515
First Posted: October 4, 2006    Key Record Dates
Results First Posted: April 26, 2011
Last Update Posted: May 6, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs