Clinical trial NCT00111800: A New Oral Treatment For Type II Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: NIDDM
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-05-26
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline (Week 0) and Week 12
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24
timeFrame: Baseline (Week 0) up to Week 24
measure: Change From Baseline in FPG at Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: 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
measure: Number of Participants Who Were HbA1c Responders at Week 12
timeFrame: Week 12
measure: Number of Participants of FPG Responders at Week 12
timeFrame: Week 12
measure: Change From Baseline in Fructosamine at Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24
timeFrame: Baseline (Week 0) up to Week 24
measure: Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: 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
measure: Change From Baseline in Pro-insulin at Week 16, 20 and 24.
timeFrame: Baseline (Week 0) up to Week 24
measure: Change From Baseline in Pro-insulin to Insulin Ratio at Week 12
timeFrame: Baseline (Week 0) and Week 12
measure: Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8
timeFrame: Baseline (Week 0) and Week 4 and 8
measure: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia
timeFrame: Up to Week 25
measure: Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe
timeFrame: Up to Week 25
measure: 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
measure: Change From Baseline in Body Weight Over Time
timeFrame: Baseline (Week 0) and Week -5 to 25 (Follow-up)
measure: Change From Baseline in Body Mass Index (BMI) Over Time
timeFrame: Baseline (Week 0) and Week -5 to 25 (Follow-up)
measure: Change From Baseline in Waist Circumference and Hip Circumference Over Time
timeFrame: Baseline (Week 0) up to Week 24
measure: Mean Change From Baseline in Waist to Hip Ratio Over Time
timeFrame: Baseline (Week 0) up to Week 24
measure: Change From Baseline in 12-lead ECG Over Time
timeFrame: Baseline (Week 0) up to Week 24
measure: Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy
timeFrame: Up to Week 24
measure: Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy
timeFrame: Up to Week 24
measure: Number of Participants With Abnormal Urinalysis Dipstick Result
timeFrame: Up to Follow-up (Week 25)
measure: Number of Participants With Urinalysis Microscopic Result
timeFrame: Up to Follow-up (Week 25)
measure: 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
measure: 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
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Oxon Hill
country: United States
facility: GSK Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Pahrump
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Johnson City
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Kettering
country: United States
facility: GSK Investigational Site
state: Ohio
city: Jefferson Hills
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sewickley
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czechia
facility: GSK Investigational Site
city: Cheb
country: Czechia
facility: GSK Investigational Site
city: Liberec
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Trebic
country: Czechia
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Bammental
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Deggingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kippenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Koenigsfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Offenburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stockach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Kreuznach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hirschhorn
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kelkheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bad Lauterberg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Lueneburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Tostedt
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Ingelheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Lavrio
country: Greece
facility: GSK Investigational Site
city: Melissia
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Ogre
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Talsi
country: Latvia
facility: GSK Investigational Site
city: Valmiera
country: Latvia
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: