Last updated: 11/04/2018 06:11:51

A New Oral Treatment For Type II Diabetes Mellitus

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GSK study ID
DPB100925
See study documents
Clinicaltrials.gov ID
NCT00111800
See results summary
EudraCT ID
2004-004193-91
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension
Trial description: This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Change from Baseline in HbA1c at Week 4, 8, 16, 20 and 24

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in FPG at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24

Timeframe: Baseline (Week 0) up to Week 24

Number of participants who were HbA1c responders at Week 12

Timeframe: Week 12

Number of participants of FPG responders at Week 12

Timeframe: Week 12

Change from Baseline in fructosamine at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in fructosamine at Weeks 4, 8, 16, 20 and 24

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in fasting serum insulin and pro-insulin at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in fasting serum insulin at Weeks 4, 8, 16, 20, 24 and pro-insulin at Weeks 4 and 8

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in pro-insulin at Week 16, 20 and 24.

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in pro-insulin to insulin ratio at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in pro-insulin to insulin ratio at Week 4 and 8

Timeframe: Baseline (Week 0) and Week 4 and 8

Number of participants with any adverse events (AE) or serious adverse events (SAE) and events of hypoglycaemia

Timeframe: Up to Week 25

Number of participants with AE and event of hypoglycaemia of mild, moderate and severe

Timeframe: Up to Week 25

Number of participants with change from Baseline value of potential clinical concern (PCC) in vital signs at any time during therapy

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in body weight over time

Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)

Change from Baseline in body mass index (BMI) over time

Timeframe: Baseline (Week 0) and Week -5 to 25 (Follow-up)

Change from Baseline in waist circumference and hip circumference over time

Timeframe: Baseline (Week 0) up to Week 24

Mean change from Baseline in waist to hip ratio over time

Timeframe: Baseline (Week 0) up to Week 24

Change from Baseline in 12-lead ECG over time

Timeframe: Baseline (Week 0) up to Week 24

Number of participants with laboratory clinical chemistry values of PCC at any time on therapy

Timeframe: Up to Week 24

Number of participants with laboratory haematology values of PCC at any time on therapy

Timeframe: Up to Week 24

Number of participants with abnormal urinalysis dipstick result

Timeframe: Up to Follow-up (Week 25)

Number of participants with urinalysis microscopic result

Timeframe: Up to Follow-up (Week 25)

Population pharmacokinetic (PK) parameter of plasma concentration of DEN

Timeframe: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Descriptive statistics of dipeptidyl peptidase-IV (DPP-IV) inhibition performed as part of the population PK

Timeframe: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Interventions:
  • Drug: Placebo
  • Drug: DEN 2.5 mg
  • Drug: DEN 7.5 mg
  • Drug: DEN 15 mg
  • Drug: DEN 30 mg
  • Drug: DEN 45 mg
    • Enrollment:
    375
    Primary completion date:
    2006-26-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    denagliptin
    Collaborators
    Not applicable
    Study date(s)
    April 2005 to April 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Women must not be pregnant and must not be breastfeeding.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Women must not be pregnant and must not be breastfeeding.
    • Have Type II diabetes.
    • Not taking any medicine for diabetes, or taking one oral medicine for their diabetes. Exclusion criteria:
    • Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Kuopio, Finland, 70210
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Albany, New York, United States, 12208
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oxon Hill, Maryland, United States, 20745
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Deggingen, Baden-Wuerttemberg, Germany, 73326
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oulu, Finland, 90100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ingelheim, Rheinland-Pfalz, Germany, 55218
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 106 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-26-04
    Actual study completion date
    2006-26-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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