Last updated: 11/04/2018 05:17:36
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Trial description: This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
Timeframe: 24 weeks
Secondary outcomes:
glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks
Timeframe: 8, 16, and 24 weeks
Interventions:
Drug: Rosiglitazone 4 mg
Enrollment:
256
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
October 2005 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Inclusion:
- Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion:
- Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
- If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level>7.5%. Exclusion:
- Fasting plasma glucose >13 mmol/L at screening
- Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
- Drug abuse
- Women pregnant or lactating
- Use any rosiglitazone like drug in 3 months
- Use more than one oral antidiabetic agent in 2 months
- Uncontrolled hypertension
- Chronic heart failure
- Anemia
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-23-11
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
Additional information
Not applicable
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