A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Type 2 Diabetics

NCT01013766 | Completed Phase 1

• 1 other identifier: 111823
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This study is the second administration of GSK1362885 in humans. GSK1362885 is a novel, potent inhibitor of human glycogen phosphorylase (GP) under development for the treatment of type 2 diabetes mellitus (T2DM). This study will investigate the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

GSK1362885; Pharmacodynamics; Safety; Pharmacokinetics; T2DM; Tolerability

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability assessments including adverse events and clinical laboratory tests

  7 Days

• Pharmacodynamics following oral administration (glucose, insulin, c-peptide)

  24 hours

• Pharmacokinetic parameters: AUC, Cmax, Tmax, t1/2, tlag, Cl/F, and V/F

  24 hours

Secondary Outcomes (2)

• Pharmacodynamics following BID administration (glucose, insulin, c-peptide)

  24 hours

• Relationship between pharmacokinetic and pharmacodynamic parameters

  24 hours

Study Arms (2)

AM/PM/BID

OTHER

Subjects will receive a dose of 100mg in the AM on Day 1, followed by a dose of 100mg in the PM on Day 4, and a dose of 50mg BID on Day 6.

Drug: GSK1362885

PM/AM/BID

OTHER

Subjects will receive a dose of 100mg in the PM on Day 1, followed by a dose of 100mg in the AM on Day 4, followed by 50mg BID on Day 6.

Drug: GSK1362885

Interventions

GSK1362885 DRUG

100mg in the AM, 100mg in the PM, 50mg BID

AM/PM/BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Male or female between 18 and 65 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/premature ovarian failure defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (\<140 pmol/L) is confirmatory.
• BMI within the range 22 to 38 kg/m2 (inclusive).
• T2DM diagnosed at least 3 months prior to Screening with:
• Fasting plasma glucose (FPG) level less than or equal to 250mg/dL at the Screening visit,
• FPG level less than or equal to 270 mg/dL on Day -2
• For subjects taking no antidiabetic medications: HbA1c between 6.5 and 11 percent, inclusive, at Screening visit
• For subjects taking one or two antidiabetic medications: HbA1c between 5.8 and 10 percent, inclusive, at Screening visit
• Subjects must be treating their T2DM using one of the following regimens:
• Diet and exercise therapy
• Metformin as monotherapy
• Sulfonylurea as monotherapy
• Metformin and sulfonylurea in combination, if one or both component(s) is being administered at a dose that is less than the maximum dose
• DPP-IV inhibitors, either as monotherapy, or in combination with other agent(s) on this list, if one or both component(s) is being administered at a dose that is less than the maximum dose
• Exenatide, either as monotherapy or in combination with other agent(s) on this list, if one or both component(s) is being administered at a dose that is less than the maximum dose

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Phoenix, Arizona, 85013, United States

Location

GSK Investigational Site

Saint Paul, Minnesota, 55114-1067, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 111823 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 16, 2009
• Study Start: August 13, 2009
• Primary Completion: November 20, 2009
• Study Completion: November 20, 2009
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)