Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions
Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Repaglinide (Drug); Metformin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Chinese PLA General Hospital Official(s) and/or principal investigator(s): Chunlin Li, M.D&Ph.D, Principal Investigator, Affiliation: PLA General Hospital
Overall contact: Chunlin Li, M.D & Ph.D, Phone: +86-13661285276, Email: lcl301@yahoo.com.cn
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.
Clinical Details
Official title: Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions in Newly Diagnosed Type 2 Diabetes Patients in China
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: 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
Detailed description:
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.
Eligibility for participation will be determined by medical history, physical examination,
and laboratory results obtained during a screening visit (see trail population). About 60
patients with newly diagnosed (within 6 months) type 2 diabetes and both insulin and oral
antidiabetic drugs (OAD) naïve will be include in this study. All subjects will be given
informed consent before starting any examination and test. Then the 24h blood glucose of
each patient will be recorded by utilizing continue glucose monitor system (CGMS). Besides
that, the following data of all subject will be collected: HbA1c, Fasting blood glucose, 2h
postprandial blood glucose, fasting lipid profile, 2h postprandial lipid profile, fasting
uric acid, 2h postprandial uric acid, fasting insulin and proinsulin, 2h postprandial
insulin and proinsulin, fasting C peptide, 2h postprandial C peptide, fasting glucagon, 2h
postprandial glucagon.
After baseline data are collected, eligible subjects will be randomized into each group at a
2: 1 ratio (40 for repaglinide and 20 for metformin). IVGTT and hyperinsulinemic-euglycemic
clamp will be done to 20 patients in repaglinide group and 10 patients in metformin group
(less than 20% drop-off rate is acceptable for this study). Follow that, all patients will
start to receive either repaglinide thrice daily (immediately before breakfast lunch, and
dinner) or metformin thrice daily (after breakfast, lunch and dinner). The initial
repaglinide doses will be based on HbA1c levels on the day of randomization (0. 5 mg tid for
HbA1c < 8% and 1 mg tid for HbA1c ≥ 8%); the initial dosage for metformin will be 0. 5 g tid
and this dosage will be kept until the end of this study.
Treatment diaries will be asked for every subject to record glucose levels (7 times per day
and 2 days per week for the first three weeks, then 7 times per day and 1 day per week until
the end of this study), diet and exercise, stress situation, hypoglycemic symptoms and so
on. All patients will be followed by visiting clinic every week for the first three weeks,
but only patients in repaglinide group will be titrated their doses. Dose adjustment should
be aimed at achieving the following glycemic targets: fasting blood glucose: 4. 4 - 6. 0
mmol/L, 2h post prandial glucose 4. 4 - 8. 0 mmol/L. If above glycaemic target has not been
achieved, repaglinide dose should be adjusted for every week (see Schematic diagram of trial
design). The adjustment of repaglinide doses is based on the mean of blood glucose recorded
in subject diaries. The doses of repaglinide before each meal may be different, depending on
the recorded blood glucose concentrations. After three weeks titration for repaglinide
(maximal dosage for repaglinide is 2 mg tid), the patients in this group will keep the
optimal dosage for the next 12 weeks. Clinic visit will be conducted every four weeks after
the period of dosages titration to collect information, such as hypoglycemia, adverse events
and fasting blood glucose.
Complicated examinations will be repeated again after above 12 weeks treatments for both
groups, including physical examination, electrocardiogram (ECG), CGMS, fasting and 2h post
prandial glucose, concentration of insulin, proinsulin, C peptide, glucagon, uric acid and
so on. IVGTT and hyperinsulinemic-euglycemic clamp will be repeated only for subjects who
did that at the beginning of study. Data will be collected and analyzed.
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.)
2. Ages between 20-90 years
3. BMI between 18. 5 and 30 kg/m2
4. Newly diagnosed type 2 diabetes. Type 2 diabetes is in accordance with WHO criteria
1999
5. The history of diabetes less than 6 months
6. HbA1c <10%.
7. Only on diet and/or exercise, OAD or insulin naïve subjects
Exclusion Criteria:
1. Any history of OAD or insulin therapy preceding this trial.
2. Type 1 diabetic subjects, including LADA
3. 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.
4. Impaired hepatic function (ALT > 2. 5 times upper limit of local laboratories normal
ranges)
5. Impaired renal function, defined as serum creatinine ≥ 1. 5 mg/dl.
6. Use of systemic or inhaled glucocorticoids or other medication known to interfere
with glucose metabolism.
7. Recently had acute diabetic complications
8. Mental incapacity, unwillingness or language barriers precluding adequate
understanding or cooperation.
9. Recently had operation, injury, inflammation and other stress conditions.
10. Recently had cardiac disease as following:
Locations and Contacts
Chunlin Li, M.D & Ph.D, Phone: +86-13661285276, Email: lcl301@yahoo.com.cn
PLA General Hospital, Beijing, Beijing 100000, China; Recruiting Dong Cai, Phone: +86-10-66939246
Additional Information
Starting date: January 2009
Last updated: August 24, 2009
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