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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide Arm | Experimental | Exenatide and Metformin |
|
| Insulin Glargine Arm | Active Comparator | Insulin Glargine and Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell Function After 52 Weeks of Therapy | Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]). | Baseline (week -2) and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell Function 4 Weeks After Cessation of Therapy | Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vice President, Research and Development, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Helsinki | Finland | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19196887 | Result | Bunck MC, Diamant M, Corner A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U, Yki-Jarvinen H, Heine RJ. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009 May;32(5):762-8. doi: 10.2337/dc08-1797. Epub 2009 Feb 5. | |
| 39963952 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Arm | 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability. |
| FG001 | Insulin Glargine Arm | Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| On-drug Period (Week 0 to Week 52) |
|
| |||||||||||||||||||||
| Off-drug Period (Week 52 to Week 64) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Arm | 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability. |
| BG001 | Insulin Glargine Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beta-cell Function After 52 Weeks of Therapy | Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]). | Evaluable population | Posted | Least Squares Mean | Standard Error | ratio | Baseline (week -2) and 52 weeks |
|
Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide Arm | 5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA 6.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 6.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Insulin glargine | Drug | subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets |
|
|
| Metformin | Drug | Patients usual dosage |
|
| Baseline (week -2) and 56 weeks |
| Change in First Phase C-peptide Release | Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure. | baseline (week -2), 52 weeks, and 56 weeks |
| Change in Second Phase C-peptide Release | Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure. | baseline (-2 weeks), 52 weeks, and 56 weeks |
| Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0). | Week 0 and week 52 |
| Change in Fasting Plasma Glucose | Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0). | 0 weeks and 52 weeks |
| Seven Point Self Monitored Blood Glucose (SMBG) Measurements | SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime). | 0 weeks and 52 weeks |
| Change in Body Weight | Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0). | 0 weeks and 52 weeks |
| M-value at Baseline, Week 52 and Week 56 | M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp. | baseline (week -2), 52 weeks, and 56 weeks |
| Amsterdam |
| Netherlands |
| Research Site | Gothenburg | Sweden |
| Derived |
| Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2. |
| 31078666 | Derived | Muskiet MHA, Bunck MC, Heine RJ, Corner A, Yki-Jarvinen H, Eliasson B, Joles JA, Diamant M, Tonneijck L, van Raalte DH. Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. Diabetes Res Clin Pract. 2019 Jul;153:14-22. doi: 10.1016/j.diabres.2019.05.001. Epub 2019 May 9. |
| 21868779 | Derived | Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Jarvinen H, Diamant M. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7. doi: 10.2337/dc11-0291. |
| 20494360 | Derived | Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Wu Y, Yan P, Smith U, Yki-Jarvinen H, Diamant M, Taskinen MR. One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Atherosclerosis. 2010 Sep;212(1):223-9. doi: 10.1016/j.atherosclerosis.2010.04.024. Epub 2010 Apr 29. |
| Physician Decision |
|
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percentage |
|
| Duration of diabetes | Mean | Standard Deviation | years |
|
| OG001 | Insulin Glargine Arm | Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements. |
|
|
|
| Secondary | Beta-cell Function 4 Weeks After Cessation of Therapy | Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]). | Evaluable population | Posted | Least Squares Mean | Standard Error | ratio | Baseline (week -2) and 56 weeks |
|
|
|
|
| Secondary | Change in First Phase C-peptide Release | Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure. | Evaluable population. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | ratio | baseline (week -2), 52 weeks, and 56 weeks |
|
|
|
|
| Secondary | Change in Second Phase C-peptide Release | Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure. | Evaluable population. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | ratio | baseline (-2 weeks), 52 weeks, and 56 weeks |
|
|
|
|
| Secondary | Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0). | Intent to treat population. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | percent | Week 0 and week 52 |
|
|
|
|
| Secondary | Change in Fasting Plasma Glucose | Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0). | Intent to treat population. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmol/L | 0 weeks and 52 weeks |
|
|
|
|
| Secondary | Seven Point Self Monitored Blood Glucose (SMBG) Measurements | SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime). | Intent to treat population. | Posted | Mean | Standard Deviation | mmol/L | 0 weeks and 52 weeks |
|
|
|
| Secondary | Change in Body Weight | Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0). | Intent to treat population. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | kg | 0 weeks and 52 weeks |
|
|
|
|
| Secondary | M-value at Baseline, Week 52 and Week 56 | M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp. | Evaluable population. | Posted | Mean | Standard Error | mg/min/kg | baseline (week -2), 52 weeks, and 56 weeks |
|
|
|
| 3 |
| 36 |
| 32 |
| 36 |
| EG001 | Insulin Glargine Arm | Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements. | 1 | 33 | 31 | 33 |
| Pancreatitis | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Thrombophlebitis Superficial | Vascular disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Injection Site Rash | General disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Edema Peripheral | General disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 6.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 6.1 | Non-systematic Assessment |
|
Not provided
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| 0.1188 |
| 95 |
| No |
| Superiority or Other |
| 0.1996 |
| 95 |
| No |
| Superiority or Other |
| 2-hour post-breakfast measurement (week 0) |
|
| 2-hour post-breakfast measurement (week 52) |
|
| Pre-lunch measurement (week 0) |
|
| Pre-lunch measurement (week 52) |
|
| 2-hour post-lunch measurement (week 0) |
|
| 2-hour post-lunch measurement (week 52) |
|
| Pre-dinner measurement (week 0) |
|
| Pre-dinner measurement (week 52) |
|
| 2-hour post-dinner measurement (week 0) |
|
| 2-hour post-dinner measurement (week 52) |
|
| Bedtime measurement (week 0) |
|
| Bedtime measurement (week 52) |
|
| week 56 |
|