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

Steno Diabetes Centers

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin BIAsp30 (Novolog 70/30); Drug: Placebo-Metformin; Drug: Repaglinide; Drug: Metformin; Drug: Placebo-Repaglinide

Study type: Interventional

Funder types: Other

Identifiers

NCT00118963

Reform

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

102 participants in 3 patient groups

3

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Insulin BIAsp30 (Novolog 70/30)

Drug: Placebo-Repaglinide

2

Active Comparator group

Description:

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

Treatment:

Drug: Placebo-Metformin

Drug: Repaglinide

Drug: Insulin BIAsp30 (Novolog 70/30)

1

Other group

Description:

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

Treatment:

Drug: Metformin

Drug: Repaglinide