Change in HbA1c From Baseline to Week 26
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.47 | 0.05 |
| Insulin Glargine | -1.31 | 0.06 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Australia, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Mexico, Netherlands, Puerto Rico, Russia, South Korea, Spain, Taiwan
1 trial · 1 completed · 1 with posted results
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
NCT00641056Apr 2008 to Nov 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
Experimental
1
Active comparator
2
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 26
Time frame · Baseline, Week 26
Change in HbA1c from baseline to Week 26
Percentage of Patients Achieving HbA1c <=7.0% at Week 26
Time frame · Baseline, Week 26
Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline)
Percentage of Patients Achieving HbA1c <=6.5% at Week 26
Time frame · Baseline, Week 26
Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline)
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time frame · Baseline, Week 26
Change in FSG (mmol/L) from Baseline to Week 26
Change in Body Weight (BW) From Baseline to Week 26
Time frame · Baseline, Week 26
Change in BW (kg) from Baseline to Week 26
Change in Total Cholesterol From Baseline to Week 26
Time frame · Baseline, Week 26
Change in Total Cholesterol (mmol/L) from Baseline to Week 26
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
Time frame · Baseline, Week 26
Change in HDL (mmol/L) from Baseline to Week 26
Ratio of Triglycerides at Week 26 to Baseline
Time frame · Baseline, Week 26
Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Change in Blood Pressure From Baseline to Week 26
Time frame · Baseline, Week 26
Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
Time frame · Baseline to Week 26
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.47 | 0.05 |
| Insulin Glargine | -1.31 | 0.06 |
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 62.2 |
| Insulin Glargine | 54.1 |
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 43.2 |
| Insulin Glargine | 28.4 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.13 | 0.16 |
| Insulin Glargine | -2.76 | 0.16 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.63 | 0.20 |
| Insulin Glargine | 1.42 | 0.20 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.12 | 0.06 |
| Insulin Glargine | -0.04 | 0.06 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.00 | 0.01 |
| Insulin Glargine | 0.01 | 0.01 |
| Group | Value (ratio) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.96 | 0.03 |
| Insulin Glargine | 0.89 | 0.03 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklyPatients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week. | – | 11 / 233 | 100 / 233 |
| Insulin GlarginePatients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L. | – | 10 / 223 | 52 / 223 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
5 studies on this page
Indexing hint: Randomized controlled trial · 2013
Meloni et al. 2013Cardiovascular diabetologycited by 12
PMID 23522121PMC3622579DOI 10.1186/1475-2840-12-48PUB-23522121
Indexing hint: Randomized controlled trial · 2013
Grimm et al. 2013Postgraduate medicinecited by 52
PMID 23748506DOI 10.3810/pgm.2013.05.2660PUB-23748506
PubMed tag: none · 2012
Fineman et al. 2012Diabetes, obesity & metabolismcited by 117
PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356
Indexing hint: Randomized controlled trial · 2012
Diamant et al. 2012Diabetes carecited by 69
PMID 22357185PMC3308312DOI 10.2337/dc11-1233PUB-22357185
Indexing hint: Randomized controlled trial · 2010
Diamant et al. 2010Lancet (London, England)cited by 337
PMID 20609969DOI 10.1016/s0140-6736(10)60406-0PUB-20609969
2 studies on this page
PubMed tag: none · 2020
Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6
PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296
Indexing hint: Randomized controlled trial · 2014
Diamant et al. 2014The lancet. Diabetes & endocrinologycited by 131
PMID 24731672DOI 10.1016/s2213-8587(14)70029-4PUB-24731672
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