Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a 17 week, randomized, single center, open-label, parallel-group study to compare glucose excursions and other efficacy and safety parameters of repaglinide thrice daily or metformin thrice daily in newly diagnosed type 2 diabetes subjects in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jan 2009
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 25, 2009
August 1, 2009
9 months
January 29, 2009
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate the effects of monotherapy of either repaglinide or metformin on glucose excursion after 3 months treatment in newly diagnosed type 2 diabetes patients in China
from Jan.01 2009 to Oct.30,2009
Study Arms (2)
Repaglinide,tablet
ACTIVE COMPARATORMetformin, tablet
ACTIVE COMPARATORInterventions
Repaglinide (NovoNorm®): 0.5 mg/tablet, 1.0 mg/tablet
2 mg/tablet Metformin (Glucophage®): 0.5 g/tablet
Eligibility Criteria
You may qualify if:
- Informed consent obtained before any trial-related activities. (Trial- related activities are any procedure that would not have been performed during normal management of the subject.)
- Ages between 20-90 years
- BMI between 18.5 and 30 kg/m2
- Newly diagnosed type 2 diabetes. Type 2 diabetes is in accordance with WHO criteria 1999
- The history of diabetes less than 6 months
- HbA1c \<10%.
- Only on diet and/or exercise, OAD or insulin naïve subjects
You may not qualify if:
- Any history of OAD or insulin therapy preceding this trial.
- Type 1 diabetic subjects, including LADA
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (adequate contraceptive measures are sterilisation, IUD, oral contraceptives or barrier methods) before and/or during the trial.
- Impaired hepatic function (ALT \> 2.5 times upper limit of local laboratories normal ranges)
- Impaired renal function, defined as serum creatinine ≥ 1.5 mg/dl.
- Use of systemic or inhaled glucocorticoids or other medication known to interfere with glucose metabolism.
- Recently had acute diabetic complications
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Recently had operation, injury, inflammation and other stress conditions.
- Recently had cardiac disease as following:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PLA General Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunlin Li, M.D&Ph.D
PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
January 1, 2009
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
August 25, 2009
Record last verified: 2009-08