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This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.
Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide | Active Comparator | 5 μg BID for the first 4 weeks of treatment and 10 μg thereafter |
|
| Insulin glargine | Active Comparator | ≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | 5 μg BID for the first 4 weeks of treatment and 10 μg thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS) | 1±3day;112±3d |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | continuous overlapping net glycemic action (CONGA) and mean of daily differences (MODD) | 1±3day;112±3d |
| Glucose control | Glycosylated hemoglobin A 1c (HbA1c), FBG, postprandial blood glucose (PBG) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with exenatide or insulin glargine adverse events as a measure of safety and tolerability: | hypoglycemia reaction; blood glucose lower than 3.1mmol/L; nausea, vomiting, diarrhea, anorexia or abdominal pain after exenatide subcutaneous injection. | -7±3d;1±3d;7±2d;14±3d;21±2d;28±3d;35±3d;56±3d;84±3d;112±3d |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD PhD | the Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30302121 | Derived | Yin TT, Bi Y, Li P, Shen SM, Wang WM, Jiang C, Gao CX, Wang Y, Gao LJ, Zhu DL, Feng WH. Effects of exenatide versus insulin glargine on body composition in overweight and obese T2DM patients: a randomized controlled trial. Nutr Metab (Lond). 2018 Oct 1;15:67. doi: 10.1186/s12986-018-0295-6. eCollection 2018. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Insulin glargine | Drug | ≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks. |
|
|
| -7±3d;112±3d; |
| oxidative stress markers | plasma concentrations of superoxide dismutase (SOD), malondialdehyde, 8-iso-prostaglandin-F2α (8-iso-PGF2α) and urine concentrations of 8-iso-PGF2α; | 1±3d;28±3d;56±3d;84±3d;112±3d |
| inflammatory markers | plasma concentrations of interleukin-1(IL-1), interleukin-18(IL-18), adiponectin, toll-like receptor 4(TLR-4) and phosphorylated-nuclear factor-kappaB 65 (pNF-κB 65) in white blood cells | 1±3d;28±3d;56±3d;84±3d;112±3d |
| endothelial function | plasma total nitric oxide synthase (tNOS), inducible nitric oxide synthase (iNOS), nitric oxide (NO) | 1±3d;28±3d;56±3d;84±3d;112±3d |
| beta-cell function and insulin resistance | homeostasis model assessment-β, homeostasis model assessment -insulin resistance, plasma glucagon, body mass index (BMI), waist-hip ratio | 1±3d;112±3d; |
| body composition | fat mass, lean tissue, body weight, waist circumference | 1±3d;112±3d |
| Exploratory Objective assessed by the relationships between oxidative stress and inflammatory markers and MAGE |
Whether there is linear correlation between oxidative stress markers and MAGE, and between inflammatory markers and MAGE, and correlation coefficient of each correlation |
| 1±3d;112±3d |
| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |