A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.

Key facts

Study ID

NCT01119846

Run by

GlaxoSmithKline

People needed

100

Starts

2009-06-05

Expected to finish

2010-03-19

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent.
• A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40pg/ml (<140pmol/L) is confirmatory.
• Except as noted elsewhere, subjects should have no significant known medical conditions other than T2DM, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters that meets exclusion criteria but is outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• BMI (body mass index) within the range 22-35 kg/m2, inclusive.
• Part A - T2DM diagnosed by American Diabetes Association criteria at least 3 months prior to Screening with:
• Currently controlled by diet and exercise.
• Fasting plasma glucose (FPG) level <= 250mg/dL at the Screening visit
• FPG level <= 250mg/dL on Day -1
• HbA1c between 6.5 and 11%, inclusive, at Screening visit
• For Parts B and C, T2DM diagnosed by American Diabetes Association criteria at least 3 months prior to Screening with:
• T2DM currently controlled by diet and exercise, or, if on medication, subjects must be treating their T2DM using one of the following regimens:
• Metformin as monotherapy
• Sulfonylurea as monotherapy
• Metformin and sulfonylurea in combination, if both components are being administered at doses that are half their maximum dose or less
• DPP-IV inhibitors, either as monotherapy or in combination with other agent(s) on this list at half maximal dose or less
• Exenatide, either as monotherapy or in combination with other agent(s) on this list at half maximal dose or less
• For subjects that are being screened for Parts B and C, all doses of anti-diabetic medication must have been stable for at least 3 months prior to Screening, and the subject must be willing to wash out from their anti-diabetic medications from Day -7 through post-last-dose of Period 2 (Part B) or Day -7 through Day 15 (Part C).
• Fasting plasma glucose (FPG) level <= 220mg/dL at the Screening visit
• FPG level <= 250mg/dL on Day -1
• HbA1c between 7 and 11%, inclusive, at Screening visit
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if…

• Has any of the following laboratory abnormalities:
• Positive pre-study Hepatitis B surface antigen or positive Hepatitis C, result within 3 months of screening.
• Positive test for HIV antibody.
• History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH at Screening. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to Screening and who have a screening thyroid stimulating hormone (TSH) within the normal range may participate.)
• ALT and/or AST > 2 times the upper limit of normal at screening.
• Fasting triglycerides > 450mg/dL at screening.
• Total Bilirubin > 1.5 times the upper limit of normal at screening.
• For females a haemoglobin < 11.5 g/dL, and for males a hemoglobin < 12.5 g/dL. Hemoglobin < 11g/dL(A female subject with haemoglobin between 10g/dL and 11.5 g/dL, or a male subject with haemoglobin between 10g/dL and 12.5 g/dLmay be enrolled only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk to the subject and will not interfere with the study procedures).
• A positive pre-study drug/urine screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• A pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products.
• If female is pregnant or has a positive pregnancy test
• Significant renal disease as manifested by one or more of the following:
• Creatinine clearance <60mL/min. (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
• To calculate estimated GFR (mL/min/1.73m2) manually:
• =186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American) =exp (5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American)) (A link to a validated MDRD calculator on the internet is provided in the SRM.)
• Urine protein/creatinine (mg of protein/mg of creatinine) ratio >2.5; or urine albumin concentration >300mg/g of creatinine).
• Known loss of a kidney either by surgical ablation, injury, or disease.
• Significant ECG abnormalities, defined as follows:
• Heart Rate < 50 and >100bpm PR Interval <120 and > 220ms QRS duration < 70 and >120ms QTC Interval (Bazett)* > 450ms
• Or, has clinically significant rhythm abnormalities identified during 24-hour Screening Holter assessment. Subjects with Left Bundle Branch Block are excluded from the study. Subjects with partial Right Bundle Branch Block may be considered for inclusion following consultation with the GSK Medical Monitor. Subjects with WPW syndrome are excluded from the study.
• Note that if ECG abnormalities are identified, the ECG should be repeated two more times (with 5 minutes between ECG readings) and the average of the 3 values used to determine eligibility.
• Systolic pressure > 150mmHg or <80mmHg or diastolic blood pressure > 95mmHg or <60mmHg at screening. Blood pressure assessments may be repeated once if needed, allowing adequate time for subject to rest.
• Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with gestational diabetes mellitus.
• Has a history of any of the following conditions:
• Clinically significant symptoms of gastroparesis

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Chula Vista, California, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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