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This study has been withdrawn prior to enrollment.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: July 7, 2014
Last verified: July 2014

September 23, 2013
July 7, 2014
December 2013
December 2013   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01951183 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO6811135
    Subcutaneously daily
  • Drug: Placebo
    RO681135 placebo subcutaneously daily
  • Experimental: RO6811135
    Intervention: Drug: RO6811135
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01951183
NP29013
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP