A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098539
First received: April 1, 2010
Last updated: November 21, 2012
Last verified: August 2012

April 1, 2010
November 21, 2012
May 2010
May 2012   (final data collection date for primary outcome measure)
Evaluation of the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
change from baseline
Evaluation of the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01098539 on ClinicalTrials.gov Archive Site
  • HbA1c change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    change from baseline over time
  • Fasting plasma glucose (FPG) change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    change from baseline over time
  • Proportion of subjects at a HbA1c treatment goal of <7.0% or <6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    HbA1c responders
  • Time to hyperglycemia rescue [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    measure of time taken to require rescue medication
  • Change from Baseline in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    change from baseline
  • The effect of plasma concentrations of albiglutide on glycemic control (population PK/PD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    population PK/PD
  • HbA1c change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose (FPG) change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects at a HbA1c treatment goal of <7.0% or <6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Time to hyperglycemia rescue [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • The effect of plasma concentrations of albiglutide on glycemic control (population PK/PD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide
    albiglutide weekly subcutaneous injection + sitagliptin matching placebo
  • Drug: sitagliptin
    albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
  • Active Comparator: albiglutide
    albiglutide weekly subcutaneous injection + sitagliptin matching placebo
    Intervention: Biological: albiglutide
  • Active Comparator: sitagliptin
    albiglutide matching placebo + sitagliptin
    Intervention: Drug: sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
507
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
  • BMI >/=20 kg/m2 and </=45 kg/m2
  • Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
  • HbA1c between 7.0% and 10.0%, inclusive.

Exclusion Criteria:

  • History of cancer
  • History of treated diabetic gastroparesis
  • Current biliary disease or history of pancreatitis
  • History of significant gastrointestinal surgery
  • Recent clinically significant cardiovascular and/or cerebrovascular disease
  • History of human immunodeficiency virus infection
  • Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
  • Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
  • Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
  • Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Colombia,   Germany,   India,   Israel,   Korea, Republic of,   Peru,   Philippines,   Russian Federation,   South Africa,   Spain,   Taiwan,   United Kingdom
 
NCT01098539
114130
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP