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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01951183
• Other study ID #: NP29013
• Status: Withdrawn
• Phase: Phase 2
• First received: September 23, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
RO681135 placebo subcutaneously daily
• RO6811135
Subcutaneously daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		from baseline to Week 12	No
Secondary	Change from baseline in fasting plasma glucose (FPG)		from baseline to Week 12	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		12 weeks	No
Secondary	Safety: Incidence of adverse events		19 weeks	No