Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00500331 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 334
- Enrollment target
- 20
- Study locations
NCT00500331: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.
NCT00500331 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 334 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00500331, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 334 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM
Primary Outcome
Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calcu
Conditions Studied
Interventions
- OTHER Placebo
- DRUG pioglitazone
- DRUG GSK189075
Study Locations (20)
Florida
- GSK Investigational Site - Hollywood
- GSK Investigational Site - Miami
- GSK Investigational Site - Saint Cloud
Nevada
- GSK Investigational Site - Las Vegas
- GSK Investigational Site - Las Vegas
- GSK Investigational Site - Las Vegas
Buenos Aires
- GSK Investigational Site - Buenos Aries
- GSK Investigational Site - Ciudad Autonoma de Buenos Aires
- GSK Investigational Site - Ciudad Autónoma de Buenos Aires
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Córdoba
Arizona
- GSK Investigational Site - Mesa
Louisiana
- GSK Investigational Site - Sunset
Maryland
- GSK Investigational Site - Oxon Hill
New Mexico
- GSK Investigational Site - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2007-01-23 |
| Est. Completion | 2008-02-14 |
| Phase | Phase 2 |
What the finished NCT00500331 record still lists
NCT00500331 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00500331 names 20 study sites across 13 states, led by Florida, Nevada, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT00500331 about?
NCT00500331 is a clinical study titled "Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)". This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM
What is the current status of trial NCT00500331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2007-01-23. Estimated completion is 2008-02-14.
What conditions does trial NCT00500331 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00500331?
The interventions under investigation include: Placebo (OTHER), pioglitazone (DRUG), GSK189075 (DRUG).
Who is sponsoring clinical trial NCT00500331?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00500331 being conducted?
This trial has 20 study locations across Arizona, Florida, Louisiana, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00500331's enrollment target sits among peer trials
334 109th of 348 higher than 240 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
DETERMINE: Detemir vs NPH
RECRUITING · Phase 2
-
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
RECRUITING · Phase 2
-
A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
RECRUITING · Phase 2
-
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
RECRUITING · Phase 2
-
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
ACTIVE NOT RECRUITING · Phase 2
-
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05131672 · 334 participants · NA
Cast or Operation for Medial Epicondyle Fracture Treatment in Children
- NCT05131685 · 334 participants · NA
Distal Radius Interventions for Fracture Treatment
- NCT05546931 · 334 participants · NA
Mobile Health Program for Rural Hypertension
- NCT05722197 · 334 participants · NA
Assessment of Emotion Regulation Strategies Used When Suicidal
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI