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

This study has been withdrawn prior to enrollment.
(Cancelled due to Sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01951183
First received: September 23, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: RO6811135
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO6811135 Drug: RO6811135
Subcutaneously daily
Placebo Comparator: Placebo Drug: Placebo
RO681135 placebo subcutaneously daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951183

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01951183     History of Changes
Other Study ID Numbers: NP29013
Study First Received: September 23, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014