A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin

NCT00519480 | Completed Phase 1

• 1 other identifier: KG2110243
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 4

Brief Summary

This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.

Conditions

Diabetes Mellitus, Type 2

Keywords

Tolerability; GSK189075,; Metformin,; Safety,; Diabetes,

Outcome Measures

Primary Outcomes (2)

• Clinical laboratory tests, ECGs, physical exam & adverse events:

  screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)

• Home diary of blood sugar results, adverse events and drug dosing.

  throughout the study (approximately 50 days)

Secondary Outcomes (3)

• study drug blood levels:

  Dosing Days 1 & 13 metformin blood levels: Days -1 & 13

• Blood glucose & insulin levels following oral glucose challenge:

  Dosing Days -1 & 13

• fluid intake & output

  dosing Days -1 - 3, 13

Study Arms (3)

Subjects receiving treatment P

PLACEBO COMPARATOR

Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days.

Drug: Metformin; Drug: Placebo

Subjects receiving treatment A

EXPERIMENTAL

Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days.

Drug: GSK189075; Drug: Metformin

Subjects receiving treatment B

EXPERIMENTAL

Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.

Drug: GSK189075; Drug: Metformin

Interventions

GSK189075 DRUG

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

Subjects receiving treatment A; Subjects receiving treatment B

Metformin DRUG

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Subjects receiving treatment A; Subjects receiving treatment B; Subjects receiving treatment P

Placebo DRUG

Placebo will be available as an oral tablets.

Subjects receiving treatment P

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with Type 2 Diabetes for at least three months prior to study
• Diabetes treated with metformin only
• Give consent and sign an informed consent form.
• Agree to follow specific requirements of birth control during participation.

You may not qualify if:

• Type I Diabetes.
• Treatment with insulin within 3 months prior to screening
• History of diabetic ketoacidosis or lactic acidosis
• Allergy or sensitivity to metformin or similar drugs or any medical conditions which prohibit metformin use
• Excessive blood donation 56 days before the start of the study
• Urinary tract or bladder infections within four weeks of study start
• Alcohol abuse or illicit drug use within 12 months of study start
• Receiving other investigational drugs or participating in other research trials within 30 of the study start
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements with 7-14 days of study start
• Live alone without regular, daily interactions with someone who can be an emergency contact

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Miami, Florida, 33169, United States

Location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

GSK Investigational Site

Buenos Aires, 1425, Argentina

Location

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• Dobbins R, Hussey EK, O'Connor-Semmes R, Andrews S, Tao W, Wilkison WO, Cheatham B, Sagar K, Hanmant B. Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin. BMC Pharmacol Toxicol. 2021 Jun 13;22(1):34. doi: 10.1186/s40360-021-00502-0.

  PMID: 34120651 DERIVED

Related Links

• Results for study KG2110243 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: September 11, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

DE (1); AR (1); US (2)