A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

Phase 2

Withdrawn

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: RO6811135

• Registration Number: NCT01951183
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-26
• Study Start: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults between the age of 18 and 65
• Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
• Hemoglobin A1c between 7.2 and 10.5%
• Fasting plasma glucose less than 250 mg/dL
• C-peptide greater than 1.5 ng/mL
• Body mass index (BMI) between 27 and 44

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Exclusion Criteria

• Pregnant or lactating women
• Type 1 diabetes
• Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
• Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
• Significant kidney or liver disease as determined by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RO6811135	RO6811135	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose (FPG)	from baseline to Week 12
Pharmacokinetics: Area under the concentration-time curve (AUC)	12 weeks
Safety: Incidence of adverse events	19 weeks