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A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

NCT ID: NCT01376323

Last Updated: 2017-10-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-13

Study Completion Date

2012-09-17

Brief Summary

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The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

Detailed Description

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The study will be conducted at centers in Europe and the United States. The study is being conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12 weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on the results observed in part A. The emerging data from part A will be used to guide selection of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The emerging exposure response relationships from the part A interim analysis will be used to guide dose selection.

Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in period, baseline assessments, randomization, a twelve week treatment period, and a 2 week follow-up period. Following completion of the baseline visit and randomization into the study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6, 9, and 12. A subject's total participation in the study will last up to approximately 20 weeks. Subjects will continue their current prescribed regimen of metformin (glucophage) monotherapy and will monitor fasting blood glucose levels daily using a glucometer.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Safety Dose Ranging Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GSK256073 1mg bid

GSK256073 1mg capsule taken orally twice a day

Group Type EXPERIMENTAL

GSK256073 1mg

Intervention Type DRUG

GSK256073 1mg capsule

GSK256073 2mg qd

GSK256073 2 x 1mg capsule taken orally once a day

Group Type EXPERIMENTAL

GSK256073 1mg

Intervention Type DRUG

GSK256073 1mg capsule

GSK256073 5mg bid

GSK256073 5mg capsule taken orally twice a day

Group Type EXPERIMENTAL

GSK256073 5mg

Intervention Type DRUG

GSK256073 5mg capsule

GSK256073 10mg qd

GSK256073 2 x 5mg capsule taken orally once a day

Group Type EXPERIMENTAL

GSK256073 5mg

Intervention Type DRUG

GSK256073 5mg capsule

GSK256073 10mg bid

GSK256073 10mg capsule taken orally twice a day

Group Type EXPERIMENTAL

GSK256073 10mg

Intervention Type DRUG

GSK256073 10mg capsule

GSK256073 20mg qd

GSK256073 2x 10mg capsule taken orally once a day

Group Type EXPERIMENTAL

GSK256073 10mg

Intervention Type DRUG

GSK256073 10mg capsule

GSK256073 25mg bid

GSK256073 25mg capsule taken orally twice a day

Group Type EXPERIMENTAL

GSK256073 25mg

Intervention Type DRUG

GSK256073 25mg capsule

GSK256073 50mg qd

GSK256073 2x 25mg capsule taken orally once a day

Group Type EXPERIMENTAL

GSK256073 25mg

Intervention Type DRUG

GSK256073 25mg capsule

Placebo

Matching placebo capsules taken orally either once a day or twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsule

Sitagliptin 100mg qd

Commercially available Sitagliptin 100mg capsules taken once a day

Group Type ACTIVE_COMPARATOR

Sitagliptin 100mg

Intervention Type DRUG

Sitagliptin 100mg capsule

Interventions

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GSK256073 1mg

GSK256073 1mg capsule

Intervention Type DRUG

GSK256073 5mg

GSK256073 5mg capsule

Intervention Type DRUG

GSK256073 10mg

GSK256073 10mg capsule

Intervention Type DRUG

GSK256073 25mg

GSK256073 25mg capsule

Intervention Type DRUG

Placebo

placebo capsule

Intervention Type DRUG

Sitagliptin 100mg

Sitagliptin 100mg capsule

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* HbA1c levels greater than or equal to 7.0 % and less than or equal to 9.5% at Screening
* On monotherapy with metformin at the time of screening, and at a maximum tolerated dose greater than or equal to 1000 mg for at least 2 months prior to dosing.
* Fasting plasma glucose level less than 13.3 mmol/L (240 mg/dL) at Screening
* Male or female between 20 and 70 years of age, inclusive, at the time of signing the informed consent
* Fasting Triglycerides lower than 4.52 mmol/L (400 mg/dL)
* A female subject is able to participate is she if of non-child bearing potential
* Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days after last dose of the study medication
* Overweight with BMI greater than or equal to 25 kg/m2 for non-Asian Indians and greater than or equal to 24 kg/m2 for Asian-Indian, and less than 40 kg/m2
* The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Subjects in France will be eligible only if they are affiliated to or a beneficiary of a social security category
* Subjects in other countries must meet all local and/or country-specific requirements for registration and reimbursement, as applicable


* Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
* Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study
* A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C result within 3 months of screening
* Renal impairment as defined by a calculated GFR less than 60 mL/min
* Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
* Laboratory values as defined per protocol
* ECG criteria as defined per protocol
* Systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg at Screening
* History of uric acid kidney stone, and being treated with drugs for hyperuricemia including Allopurinol or Probenecid
* History of peptic ulcer disease (PUD) and/or other gastrointestinal bleeding within the 12 months prior to screening
* Use of certain blood pressure medications or certain other medications that are renally excreted as defined per protocol
* History of myopathy or CPK value greater than 3 times upper limit of normal at screening
* The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives or twice the biological effect (whichever is longer)
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day
* Any change in diet, exercise habits or smoking status within six weeks prior to screening. Any subject that cannot refrain from smoking while in the unit must be excluded
* History of sensitivity to any of the study medications, including sitagliptin or metformin, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
* The subject has a positive pre-study drug screen
* History of regular alcohol consumption within 6 months of the study as defined per protocol
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
* Pregnant females as determined by positive serum and/or urine hCG test at screening and prior to dosing
* Lactating females
* Subjects who are unwilling or unable to follow the procedures outlined in the protocol
* Subject is mentally or legally incapacitated
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Anniston, Alabama, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Miramar, Florida, United States

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Pierre-Bénite, , France

Site Status

GSK Investigational Site

Rennes, , France

Site Status

GSK Investigational Site

Rueil-Malmaison, , France

Site Status

GSK Investigational Site

Alicante, , Spain

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Granada, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Edinburgh, Midlothian, United Kingdom

Site Status

GSK Investigational Site

Cambridge, , United Kingdom

Site Status

GSK Investigational Site

Coventry, , United Kingdom

Site Status

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States France Spain United Kingdom

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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114728

Identifier Type: -

Identifier Source: org_study_id