A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Metformin; Drug: Placebo; Drug: DPP-IV Inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111631

BM18106

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Enrollment: 218 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 18-75 years of age;
• type 2 diabetes;
• stable metformin therapy for >=3 months before screening.

Exclusion criteria

• women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
• type 1 diabetes;
• any anti-hyperglycemic medication other than metformin in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Metformin

Drug: DPP-IV Inhibitor

2

Experimental group

Treatment:

Drug: Metformin

Drug: DPP-IV Inhibitor

3

Experimental group

Treatment:

Drug: Metformin

Drug: DPP-IV Inhibitor

4

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Metformin