Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

Key facts

Study ID

NCT00500331

Run by

GlaxoSmithKline

People needed

334

Starts

2007-01-23

Expected to finish

2008-02-14

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visit 1 of ≥7.0% and ≤9.5% as measured by a central laboratory. Subjects with HbA1c <7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0 prior to randomization.
• Subjects who are treatment-naïve and have not taken insulin, or any oral or injectable anti-diabetic medication in the past 3 months and have not taken a glucose lowering agent for ≥4 weeks at any time in the past, or Subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks
• Subjects who are 18 to 70 years of age inclusive at the time of Screening.
• Females of non-childbearing and childbearing potential are eligible to participate as follows:
• Women of childbearing potential must be willing to use one of the following contraception methods: intrauterine device, condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent for at least 30 days prior to the start of study medication, throughout the study and the follow-up visit. Note: use of oral contraceptives is not permitted.
• Women of non-child bearing potential are defined as follows: females regardless of age, with functioning ovaries and who have a current documented tubal ligation [Hatcher, 2004] bilateral oophorectomy or total hysterectomy, or females who are post-menopausal).
• (Post-menopausal is defined as after one year without menses with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. In addition to the above criteria, if the post-menopausal status is still questionable, a blood sample should be drawn for simultaneous measurement of follicle stimulating hormone and estradiol; values considered to confirm the post-menopausal state are respectively: FSH >40 MIU/mL and estradiol <40pg/mL (<140 pmol/L)).
• Informed Consent: a signed and dated written consent must be obtained from the subject before any procedures are performed.

You may not qualify if…

• Metabolic Disease
• Diagnosis of Type 1 diabetes mellitus.
• History of ketoacidosis which has required hospitalization.
• Thyroid disorder [TSH below the lower limit of the reference range (LLRR) of 0.4mIU/L or above the upper limit of the reference range (ULRR) of >5.5 mIU/L at Screening]. Hypothyroidism treated with the same dose and regimen of thyroid hormone replacement for at least 3 months prior to Screening is allowed.
• BMI of <22 or >43 kg/m2.
• Significant weight gain or loss (as defined as >5% of total body weight) in the 3 months prior to Screening.
• Diabetic Medication
• Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time prior to screening.
• Has taken insulin or any oral or injectable anti-diabetic medication within 3 months of screening.
• Cardiovascular Disease
• Recent history or presence of clinically significant acute cardiovascular disease including:
• Documented myocardial infarction in the 6 months prior to Screening.
• Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either planned and/or occurred in the 6 months prior to Screening.
• Unstable angina in the 6 months prior to Screening.
• Clinically significant supraventricular arrhythmias requiring medical therapy, or history of nonsustained or sustained ventricular tachycardia. Symptomatic valvular heart disease or valvular heart disease requiring therapy other than endocarditis prophylaxis.
• Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV) requiring pharmacologic treatment. NYHA Class I may be included in accordance with the local prescribing information for pioglitazone.
• Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted antihypertensive therapy, then they must be on stable dose(s) of therapy for at least 4 weeks prior to Screening.
• Has a QTc interval (Bazett's) ≥450msec at Screening on a single ECG or an average value from 3 ECGs taken 5 minutes apart (on local reading of ECG).
• Other clinically significant ECG abnormalities which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise contraindicates participation in a clinical trial with a new chemical entity.
• Fasting triglycerides ≥400mg/dL (4.56mmol/L) at Screening. If a subject is receiving permitted lipid-lowering therapy, then they must be on a stable dose(s) of therapy for at least 6 weeks prior to Screening. Niacin and bile acid sequestrants are prohibited.
• Hepatic Disease
• Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody), or clinically significant hepatic enzyme elevation including:
• Any one of the following enzymes greater than 2 times the upper limit of the reference range (ULRR) value at Screening.
• alanine transaminase (ALT).
• aspartate transaminase (AST).

Where it is running

• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Saint Cloud, Florida, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Oxon Hill, Maryland, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Canal Fulton, Ohio, United States
• GSK Investigational Site — Simpsonville, South Carolina, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Burke, Virginia, United States
• GSK Investigational Site — Buenos Aries, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Córdoba Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Argentina
• GSK Investigational Site — Mendoza, Argentina
• GSK Investigational Site — Quilmes, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Pleven, Bulgaria
• GSK Investigational Site — Plovdiv, Bulgaria
• GSK Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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