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

Completed

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

Observational study model:

Not applicable

Primary completion date:

2006-26-04

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

Participation criteria

Sex

Female & Male

Age

18 - 75 years

Accepts healthy volunteers

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.

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

Location

GSK Investigational Site

Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635

44.9 miles (71.8 km) away from your location

Status

Study Complete

Location

GSK Investigational Site

Deggingen, Baden-Wuerttemberg, Germany, 73326

56.1 miles (89.8 km) away from your location

Status

Study Complete

Location

GSK Investigational Site

Haag, Bayern, Germany, 83527

60.7 miles (97.1 km) away from your location

Status

Study Complete

Location

GSK Investigational Site

Stockach, Baden-Wuerttemberg, Germany, 78333

93.5 miles (149.6 km) away from your location

Status

Study Complete

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

Completed

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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