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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01951183

Enrollment

Registered

2013-09-26

Start date

2013-12-31

Completion date

2013-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGPlacebo

RO681135 placebo subcutaneously daily

DRUGRO6811135

Subcutaneously daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c	from baseline to Week 12

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026