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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783744

Acronym

LAPTOP

Enrollment

375

Registered

2008-11-03

Start date

2001-12-31

Completion date

Unknown

Last updated

2009-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGInsulin Glargine

In the morning to target FBG ≤ 100 mg/dl

DRUGGlimepiride

Glimepiride 3 or 4 mg

DRUGMetformin

At least 850 mg od

DRUGInsulin monotherapy with premixed insulin NPH 30/70

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change of nocturnal & mean daytime blood glucose	baseline to endpoint
Change of fasting plasma glucose	baseline to endpoint and all visits
Change of fasting blood glucose	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
Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)	Baseline to endpoint

Countries

Austria, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026