Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Repaglinide; Drug: Metformin	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions in Newly Diagnosed Type 2 Diabetes Patients in China
Study Start Date :	January 2009
Estimated Primary Completion Date :	October 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Repaglinide,tablet	Drug: Repaglinide; Repaglinide (NovoNorm®): 0.5 mg/tablet, 1.0 mg/tablet; Other Name: Repaglinide (NovoNorm®): 0.5 mg/tablet
Active Comparator: Metformin, tablet	Drug: Metformin; 2 mg/tablet Metformin (Glucophage®): 0.5 g/tablet; Other Name: Metformin (Glucophage®): 0.5 g/tablet

Outcome Measures

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Primary Outcome Measures :

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 [ Time Frame: from Jan.01 2009 to Oct.30,2009 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Chunlin Li, M.D & Ph.D	+86-13661285276	lcl301@yahoo.com.cn

Locations

China, Beijing
PLA General Hospital	Recruiting
Beijing, Beijing, China, 100000
Contact: Dong Cai +86-10-66939246

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

Principal Investigator:	Chunlin Li, M.D&Ph.D	PLA General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chinese PLA General Hospital
ClinicalTrials.gov Identifier:	NCT00832481 History of Changes
Other Study ID Numbers:	NovoNorm 301 Chunlin Li
First Posted:	January 30, 2009
Last Update Posted:	August 25, 2009
Last Verified:	August 2009

Keywords provided by Chinese PLA General Hospital:

Repaglinide; Metformin

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Repaglinide; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs