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Completed

NCT Number: NCT00118963

Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

Aim:

The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.

Methodology:

Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.

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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

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-obese patients (BMI < 27 kg/m2)
  • Type 2 diabetes
  • Age 40 years or older
  • HbA1c = 6.5% or higher at baseline.

Exclusion criteria

  • 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.
  • Weight-loss of more than 5 kg during the last 6 month prior to enrollment.

Treatment and study plan

metformin

Drug

Tablets of 500 mg; 1000 mg two times daily.

Insulin BIAsp30 (Novolog 70/30)

Drug

Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.

repaglinide

Drug

Tablets of 1 mg; Dosage: 2 mg three times daily.

Placebo-Metformin

Drug

Tablets corresponding to 500 mg; two tablets two times daily.

Placebo-Repaglinide

Drug

Tablet corresponding to 1 mg; two tablets three times daily.

Primary outcomes

  1. Glycemic control (HbA1c).

Secondary outcomes

  1. Hypoglycaemic events

  2. Home monitored plasma-glucose profiles

  3. Insulin-dose

  4. Non-glycemic cardiovascular risk factors: 24h blood-pressure measurement

  5. 24h urinary albumin excretion-rate.

  6. Fasting and postprandial 5-point-profiles of total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, free fatty acids, p-glucose, c-peptide and insulin after a standard test-meal

  7. Markers of endothelial dysfunction, inflammation and fibrinolysis including Small-dense-LDL, Lp(a) and Apo B100, von Willebrand-factor, ICAM, VCAM, selectin, endothelin, Amadori-protein, CRP, fibrinogen, IL-6, TNF-alfa, ADMA, PAI- and t-PA-activity

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Effect 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jul 12, 2005
Registry last updated
Dec 8, 2008

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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