Completed

Repaglinide vs Metformin with Insulin Biasp30 for Non-Obese Type-2-Diabetes Patients

Study Aim

This study aims to compare the effectiveness of Repaglinide and Metformin, when used with Insulin Biasp30, in managing blood sugar levels (HbA1c) in non-obese individuals with Type 2 Diabetes.

What is being tested

Metformin

+ Repaglinide

+ Insulin BIAsp30 (Novolog 70/30)

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 40 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: January 2003

See protocol details

Summary

Principal SponsorSteno Diabetes Center Copenhagen

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2003

Actual date on which the first participant was enrolled.

After four months run-in with repaglinide plus metformin combination-therapy, patients with HemoglobinA1c ≥6.5% will be randomized (baseline=0 month) to repaglinide 2 mg thrice-daily or metformin 1g twice-daily, both in combination with BIAsp30 (30% insulin-aspart; 70% protaminated insulin-aspart) (6U once-daily, pre-dinner) for 12 months.

Official TitleEffect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents

NCT00118963

Principal SponsorSteno Diabetes Center Copenhagen

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

102 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

Non-obese patients (BMI < 27 kg/m2)

Type 2 diabetes

Age 40 years or older

HbA1c = 6.5% or higher at baseline.

5 exclusion criteria prevent from participating

No known contraindications for either of the study-drugs (known allergy to the study-drugs; heart-, liver- or kidney-failure)

Pregnancy

Other serious physical or mental illnesses with a life-shortening prognosis.

Drug or alcohol abuse.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Run-in period of four months duration with Repaglinide 6 mg daily plus Metformin 2000 mg daily. No masking of interventions.

Group II

Active Comparator

BIAsp30 plus Metformin plus Placebo-Repaglinide. Double-Masked and randomized. Duration: 12 months.

Group III

Active Comparator

BIAsp30 plus Repaglinide plus Placebo-Metformin. Double-masked and randomized. Duration: 12 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Steno Diabetes Center

Gentofte Municipality, DenmarkOpen Steno Diabetes Center in Google Maps

CompletedOne Study Center