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

October 31, 2008
September 25, 2009
December 2001
August 2003   (final data collection date for primary outcome measure)
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % [ Time Frame: At endpoint ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783744 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Insulin Glargine Combination Therapies in Type II Diabetics
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • Drug: Insulin monotherapy with premixed insulin NPH 30/70
    Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl
  • Experimental: 1
    Insulin Glargine + Glimepiride + Metformin
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Glimepiride
    • Drug: Metformin
  • Active Comparator: 2
    Insulin monotherapy with premixed insulin NPH 30/70
    Intervention: Drug: Insulin monotherapy with premixed insulin NPH 30/70
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
375
Not Provided
August 2003   (final data collection date for primary outcome measure)

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.

Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   United Kingdom,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland,   Finland
 
NCT00783744
HOE901_4027
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Christine Kliebe-Frisch, MD Sanofi
Sanofi
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP