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OpenTrials
Completed

NCT Number: NCT00783744

Insulin Glargine Combination Therapies in Type II Diabetics

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi aventis administrative office, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

In the morning to target FBG ≤ 100 mg/dl

Glimepiride

Drug

Glimepiride 3 or 4 mg

metformin

Drug

At least 850 mg od

Insulin monotherapy with premixed insulin NPH 30/70

Drug

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

Primary outcomes

  1. Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %

    Time frame: At endpoint

Secondary outcomes

  1. Change of fasting blood glucose

    Time frame: baseline to endpoint

  2. Change of nocturnal & mean daytime blood glucose

    Time frame: baseline to endpoint

  3. Change of fasting plasma glucose

    Time frame: baseline to endpoint and all visits

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

    Time frame: Baseline to endpoint

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

    Time frame: Baseline to endpoint

  6. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: LAPTOP

Important dates

Study start
2001
Primary completion
2003
First posted
Nov 3, 2008
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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