Insulin Glargine "All to Target" Trial

NCT00384085 | Completed Phase 4 Results

• 1 other identifier: HMR1964A_3515
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  At week 60

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

  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.

  At week 60

• 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)

  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.

  At week 60

Secondary Outcomes (5)

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

  From baseline to week 60

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

  At week 60

• 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

  At week 60

• Adjusted Incidence Rate of Hypoglycemia

  Week 60

• Adjusted Hypoglycemic Event Rates (Event/Patient-year)

  Week 60

Study Arms (3)

Lantus/Apidra-3

EXPERIMENTAL

Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.

Drug: Insulin Glargine; Drug: Insulin Glulisine

Lantus/Apidra-1

EXPERIMENTAL

Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.

Drug: Insulin Glulisine; Drug: Insulin Glargine

Novolog Mix 70/30

EXPERIMENTAL

Premixed insulin (Novolog® Mix 70/30) added to oral agents.

Drug: Premixed Insulin

Interventions

Insulin Glulisine DRUG

Subcutaneous injection up to 1 injection per day

Also known as: Apidra

Lantus/Apidra-1

Insulin Glargine DRUG

Subcutaneous injection once-a-day

Also known as: Lantus

Lantus/Apidra-1; Lantus/Apidra-3

Premixed Insulin DRUG

Subcutaneous injection twice-a-day.

Also known as: Novolog Mix 70/30

Novolog Mix 70/30

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Location

Related Publications (1)

• Polonsky WH, Thompson S, Wei W, Riddle MC, Chaudhari S, Jackson J, Bruno AS. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab. 2014 Nov;16(11):1121-7. doi: 10.1111/dom.12328. Epub 2014 Jul 12.

  PMID: 24919603 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Glargine; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Trial Transparency Team
• Organization: sanofi-aventis

Contact-US@sanofi-aventis.com

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 4, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 6, 2011
• Results First Posted: April 26, 2011

Record last verified: 2011-05

Locations

US (1)