Insulin Glargine Combination Therapies in Type II Diabetics (LAPTOP)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783744
First received: October 31, 2008
Last updated: September 25, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: Glimepiride
Drug: Metformin
Drug: Insulin monotherapy with premixed insulin NPH 30/70
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % [ Time Frame: At endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of fasting blood glucose [ Time Frame: baseline to endpoint ] [ Designated as safety issue: No ]
  • Change of nocturnal & mean daytime blood glucose [ Time Frame: baseline to endpoint ] [ Designated as safety issue: No ]
  • Change of fasting plasma glucose [ Time Frame: baseline to endpoint and all visits ] [ Designated as safety issue: No ]
  • Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: At endpoint ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: December 2001
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783744

Locations
Austria
Sanofi aventis administrative office
Vienna, Austria
Finland
Sanofi-aventis administrative office
Helsinki, Finland
France
Sanofi-aventis administrative office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Christine Kliebe-Frisch, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783744     History of Changes
Other Study ID Numbers: HOE901_4027
Study First Received: October 31, 2008
Last Updated: September 25, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Hypoglycemic Agents
Insulin, NPH
Metformin
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014