Insulin Glargine Combination Therapies in Type II Diabetics

NCT00783744 | Completed Phase 3

• 1 other identifier: HOE901_4027
• Study Type: interventional
• Target: 375
• Locations: 10 countries
• Sites: 10

Brief Summary

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %

  At endpoint

Secondary Outcomes (6)

• Change of fasting blood glucose

  baseline to endpoint

• Change of nocturnal & mean daytime blood glucose

  baseline to endpoint

• Change of fasting plasma glucose

  baseline to endpoint and all visits

• Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)

  Baseline to endpoint

• Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)

  Baseline to endpoint

Study Arms (2)

1

EXPERIMENTAL

Insulin Glargine + Glimepiride + Metformin

Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin

2

ACTIVE COMPARATOR

Insulin monotherapy with premixed insulin NPH 30/70

Drug: Insulin monotherapy with premixed insulin NPH 30/70

Interventions

Insulin Glargine DRUG

In the morning to target FBG ≤ 100 mg/dl

1

Glimepiride DRUG

Glimepiride 3 or 4 mg

1

Metformin DRUG

At least 850 mg od

1

Insulin monotherapy with premixed insulin NPH 30/70 DRUG

Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

2

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
• HbA1c value ≥ 7.5 % to ≤ 10.5 %
• FBG ≥ 120 mg/dl (6.6 mmol/l)
• BMI ≤ 35 kg/m²
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Sanofi aventis administrative office

Vienna, Austria

Location

Sanofi-aventis administrative office

Helsinki, Finland

Location

Sanofi-aventis administrative office

Paris, France

Location

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Location

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; glimepiride; Metformin

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; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Christine Kliebe-Frisch, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: December 1, 2001
• Primary Completion: August 1, 2003
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

FI (1); NL (1); CH (1); ES (1); DE (1); FR (1); AU (1); IT (1); SE (1); GB (1)