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Insulin Glargine "All to Target" Trial

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin Glulisine (Drug); Insulin Glargine (Drug); Premixed Insulin (Drug); Insulin Glulisine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Medical Affairs, Study Director, Affiliation: Sanofi

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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)

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population

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)

Secondary outcome:

Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)

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

Adjusted Incidence Rate of Hypoglycemia

Adjusted Hypoglycemic Event Rates (Event/Patient-year)

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Additional Information

Starting date: May 2006
Last updated: May 4, 2011

Page last updated: August 23, 2015

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