Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Key facts

Study ID

NCT00495469

Run by

GlaxoSmithKline

People needed

250

Starts

2007-08-17

Expected to finish

2008-06-05

Last updated by the study team

2017-10-30

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 HbA1c ≥7.0% and ≤9.5% measured by the central laboratory at Visit 1.
• Note: Subjects with HbA1c <7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0, prior to randomization.
• Note: The proportion of subjects who are randomized with an HbA1c <7.5% will be limited to be no more than 20% (approximately 51 subjects)
• 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 childbearing and non-childbearing and 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 who have a current documented tubal ligation, or who are surgically sterile (i.e. documented total hysterectomy or bilateral oophorectomy), or females who are post-menopausal.
• All females must have a negative urine pregnancy test on the day of, and prior to randomization.
• 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 <0.4 MIU/L (<0.4 MCIU/mL) or >5.5 mIU/L (>5.5 MCIU/mL) at Screening
• BMI of <22 kg/m2 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 within 3 months of screening
• Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time in the past
• 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 or the NYHA Class criteria 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.
• Based on local readings, the subject has an initial QTc interval (Bazett's)≥450msec at Screening, and after two additional ECGs taken 5 minutes apart, the average of the QTC interval from the three ECGs is ≥450msec.
• Other clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of efficacy or 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 aminotransferase (ALT)

Where it is running

• GSK Investigational Site — Artesia, California, United States
• GSK Investigational Site — Buena Park, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Greenbrae, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Norwalk, California, United States
• GSK Investigational Site — Petaluma, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Mateo, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Deland/Florida, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Jacksonville/Florida, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Ocoee/Florida, Florida, United States
• GSK Investigational Site — Saint Cloud, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Bloomingdale, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Oak Brook, Illinois, United States
• GSK Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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