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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01951183
Recruitment Status : Withdrawn (Cancelled due to Sponsor's decision)
First Posted : September 26, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO6811135 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
RO681135 placebo subcutaneously daily
Experimental: RO6811135 Drug: RO6811135
Subcutaneously daily


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: from baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 12 ]
  2. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 12 weeks ]
  3. Safety: Incidence of adverse events [ Time Frame: 19 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951183


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01951183     History of Changes
Other Study ID Numbers: NP29013
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs