Insulin Glargine Combination Therapies in Type II Diabetics (LAPTOP)

28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin; Drug: Insulin monotherapy with premixed insulin NPH 30/70

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Sanofi aventis administrative office
• Finland
  • Helsinki, Finland
    • Sanofi-Aventis Administrative Office
• France
  • Paris, France
    • Sanofi-Aventis Administrative Office
• Germany
  • Berlin, Germany
    • Sanofi-Aventis Administrative Office
• Italy
  • Milan, Italy
    • Sanofi-Aventis Administrative Office
• Netherlands
  • Gouda, Netherlands
    • Sanofi-Aventis Administrative Office
• Spain
  • Barcelona, Spain
    • Sanofi-Aventis Administrative Office
• Sweden
  • Bromma, Sweden
    • Sanofi-Aventis Administrative Office
• Switzerland
  • Geneva, Switzerland
    • Sanofi-Aventis Administrative Office
• United Kingdom
  • Guildford, United Kingdom
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Insulin Glargine + Glimepiride + Metformin	Drug: Insulin Glargine; In the morning to target FBG ≤ 100 mg/dl; Drug: Glimepiride; Glimepiride 3 or 4 mg; Drug: Metformin; At least 850 mg od
Active Comparator: 2; Insulin monotherapy with premixed insulin NPH 30/70	Drug: Insulin monotherapy with premixed insulin NPH 30/70; Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %	At endpoint

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)	At endpoint

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Christine Kliebe-Frisch, MD, Sanofi

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): August 1, 2003

Study Registration Dates

• First Submitted: October 31, 2008
• First Submitted That Met QC Criteria: October 31, 2008
• First Posted (Estimate): November 2, 2008

Study Record Updates

• Last Update Posted (Estimate): September 28, 2009
• Last Update Submitted That Met QC Criteria: September 25, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: HOE901_4027