A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01789788

First received: February 8, 2013

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2013

Last Updated Date

September 1, 2016

Start Date ^ICMJE

March 2013

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01789788 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
Pharmacodynamics of RO681135: Blood analysis [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

Official Title ^ICMJE

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Patients With Type 2 Diabetes Mellitus.

Brief Summary

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus Type 2

Intervention ^ICMJE

Drug: Placebo
Matching placebo, multiple doses
Drug: RO6811135
multiple ascending doses

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Drug: Placebo
Experimental: RO6811135
Intervention: Drug: RO6811135

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2013

Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, 18 to 65 years of age, inclusive
Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
On stable dose of metformin for at least 2 months prior to screening
Fasting plasma glucose during the screening period </= 240 mg/dL
Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and </= 10.5%
Evidence of insulin secretory capacity at screening
Body mass index (BMI) 27 to 42 kg/m2, inclusive
Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

Type 1 diabetes
Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
History or presence of clinically significant concomitant disease or disorder
Hemoglobin level below the lower limit of reference range at screening
Pregnant or lactating women
History of anaphylaxis or severe systemic hypersensitivity or allergic reactions

Gender

Both

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01789788

Other Study ID Numbers ^ICMJE

BP28436

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

September 2016

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

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