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: DPP-IV Inhibitor; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111670

BM18102

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Enrollment: 291 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 diagnosed >=1 month before screening;
• no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion criteria

• type 1 diabetes;
• type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
• patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DPP-IV Inhibitor

2

Experimental group

Treatment:

Drug: DPP-IV Inhibitor

3

Experimental group

Treatment:

Drug: DPP-IV Inhibitor

4

Experimental group

Treatment:

Drug: DPP-IV Inhibitor

5

Placebo Comparator group

Treatment:

Drug: Placebo