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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide Arm | Experimental | exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks |
|
| Insulin Glargine Arm | Active Comparator | subcutaneous injection, once daily; forced titration to target blood glucose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide (AC2993) | Drug | subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from baseline to week 26 | Baseline, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving HbA1c <=7% | Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%). | 26 weeks |
| Change in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research-San Diego | San Diego | California | 92108 | United States | ||
| Dorothy L. and James E. Frank Diabetes Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16230722 | Result | Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG; GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2005 Oct 18;143(8):559-69. doi: 10.7326/0003-4819-143-8-200510180-00006. | |
| 22913891 | Derived | Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567. |
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Two patients were lost to follow-up after receiving study drug, and it is not known if they took at least one dose of the drug. For purposes of data analysis, these patients were classified as untreated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide Arm | Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks) |
| FG001 | Insulin Glargine Arm | Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Insulin glargine | Drug | subcutaneous injection, once daily; forced titration to target blood glucose level |
|
|
Change in body weight from baseline to week 26 |
| Baseline, week 26 |
| Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline to week 26 | Baseline, week 26 |
| Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26 | Baseline, week 26 |
| Percentage of Patients With Hypoglycemic Events | Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study | 26 weeks |
| Change in Rate of Hypoglycemic Events | Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26 | Baseline, week 26 |
| San Mateo |
| California |
| 94401 |
| United States |
| Internal Medicine Associates Department of Research | Fort Myers | Florida | 33901 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Baptist Diabetes Associates | Miami | Florida | 33176 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Springfield Diabetes & Endocrine Center | Springfield | Illinois | 62704 | United States |
| Frederick Primary Care Associates | Frederick | Maryland | 21702 | United States |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | United States |
| Lovelace Scientific Resources, Inc. | Las Vegas | Nevada | 89102 | United States |
| Diabetes, Endocrine & Nutrition | Hampton | New Hampshire | 03842 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| Great Lakes Medical Research | Westfield | New York | 14787 | United States |
| DOCS, Beth Israel Medical Center | Yonkers | New York | 10710 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Jon Shapiro, MD | Philadelphia | Pennsylvania | 19146 | United States |
| Endocrinology Consultants of East Tennessee | Knoxville | Tennessee | 37909 | United States |
| Israel Hartman, MD | Arlington | Texas | 76014 | United States |
| Diabetes & Glandular Research Associates, P.A. | San Antonio | Texas | 78229 | United States |
| Jack Wahlen, MD | Ogden | Utah | 84403 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98055 | United States |
| Australian Clinical Research Centre | Miranda | New South Wales | 2228 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Clinical Trial and Research Unit | Wollongong | New South Wales | 2500 | Australia |
| Royal Brisbane Hospital | Brisbane | Queensland | 4029 | Australia |
| Royal Adelaid Hospital | Adelaid | South Australia | 5000 | Australia |
| Repatriation General Hospital | Daw Park | South Australia | 5041 | Australia |
| SA Endocrine Clinical Research | Keswick | South Australia | 5035 | Australia |
| Eastern Health (Box Hill Hospital) | Box Hill | Victoria | 3128 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Freemantle Hospital | Freemantle | Western Australia | Australia |
| UZ Antwerpen | Endegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Sart Tilman | Liège | 4000 | Belgium |
| A.Z. Jan Palfijn | Merksem | 2170 | Belgium |
| Sint Niklaasstraat | Sint-Gillis-Waas | 9170 | Belgium |
| Hospital Nossa Senhora das Gracas | Curitiba | PR 80810-990 | Brazil |
| Centro Integrado de Diabetes e Hipertensao | Fortaleza | CE 601200-020 | Brazil |
| Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC | Fortaleza | CE 60430-350 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS 90020-090 | Brazil |
| Eiran Sairaala c/o9 Clires | Helsinki | Finland |
| Torikeskuksen Laakariasema, Yliopistonkatu | Jyväskylä | Finland |
| Oulu Deakoness Institution | Oulu | 90100 | Finland |
| Diabetologische Schwerpunktpraxis | Aschaffenburg | 63739 | Germany |
| Diabetologische Scherpunktpraxis | Bosenheim | 55545 | Germany |
| Diabetologische Schwerpunktpraxis | Dortmund | 44137 | Germany |
| Krankenhaus Bethanien | Hamburg | 20251 | Germany |
| Universitatskliniken des Saarlandes | Homburg/Saar | 66421 | Germany |
| IKFE GmbH | Mainz | Germany |
| Profil Institut fur Stoffwechselforschung GmbH | Neuss | Germany |
| Diabetologische Schwerpunktpraxis | Neuwied | 56564 | Germany |
| Diabetes Centrum Bilthoven | Bilthoven | 3723 MB | Netherlands |
| Atrium Medisch Centrum Brunssum | Brunssum | 6422 BE | Netherlands |
| Sint Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| Refaja ziekenhuis | Stadskanaal | 9501 HE | Netherlands |
| Medisch Centrum | Westeinde | Netherlands |
| Markeveien Spesialistpraksis | Bergen | 5012 | Norway |
| Spesiallegetjenesten AS | Jessheim | 2050 | Norway |
| Betanien Spesialistsenter | Oslo | 0172 | Norway |
| Sykehuset Asker of Baerum HF | Rud | 1309 | Norway |
| Forskningsstiftelsen Hjertelaget | Stravanger | 4011 | Norway |
| Bydgoskie Centrum Diabetologii i Endokrynologii | Bydgoszcz | 85-822 | Poland |
| Oddzial Chorob Wewnetrznych | Częstochowa | 42-200 | Poland |
| NZOZ "Diab-Endo-Met" | Krakow | Poland |
| Poradnia Diabetologiczna | Lodz | Rzgowska 281/289 | Poland |
| Poradnia Diabetologiczna | Lublin | 20-718 | Poland |
| Oddzial Chorob Wewnetrznych | Mielec | 39-300 | Poland |
| Oddzial Chorob Wewnetrznych i Diabetologii | Warsaw | 02-507 | Poland |
| Wojewodzka Poradnia dla Chorych na Cukrzyce | Warsaw | 03-242 | Poland |
| Hospital Garcia de Orta-Servico de Endocrinologia | Almada | 2805-267 | Portugal |
| Centro Hospitalar de Coimbra | Coimbra | 3040-853 | Portugal |
| Associacao Protectora dos Diabeticos de Portugal | Lisbon | 1250-203 | Portugal |
| Hospital Geral de Santo Antonio | Porto | 4099-001 | Portugal |
| Universidad Central del Caribe | Bayamón | 00956 | Puerto Rico |
| Hospital Alejandro Otero Lopez | Manati | 00674 | Puerto Rico |
| Dr. Luis Ruiz | Ponce | 00733 | Puerto Rico |
| RCMI-Clinical Research Center | Rio Piedras | 00935 | Puerto Rico |
| San Juan Health Center | San Juan | 00936-3833 | Puerto Rico |
| Centro de Endocrinologia del Este | Yabucoa | 00767 | Puerto Rico |
| Hospital Vega Baja | Alicante | 03300 | Spain |
| Hospital Doce de Octubre | Madrid | 28041 | Spain |
| Hospital Gral de Mostoles | Madrid | 28934 Mostoles | Spain |
| Hospital Virgen de Valme | Seville | 41014 | Spain |
| Hospital la Ribera, Alzira | Valencia | 46600 Alzira | Spain |
| Lundberglaboratoriet for diabetesforskning | Gothenburg | 413 45 | Sweden |
| Medicinska kliniken | Helsingborg | 251 87 | Sweden |
| Kliniska Forskningsenheren | Lund | 221 85 | Sweden |
| Diabetesmottagningen, Intermedicinska kliniken | Stockholm | 118 83 | Sweden |
| CME, M71 | Stockholm | 141 86 | Sweden |
| Enheten for metabol kontroll | Stockholm | 171 76 | Sweden |
| 22236356 | Derived | Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. |
| Received Treatment (Intent to Treat) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide Arm | Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks) |
| BG001 | Insulin Glargine Arm | Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from baseline to week 26 | Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post baseline data | Posted | Least Squares Mean | Standard Error | percentage | Baseline, week 26 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving HbA1c <=7% | Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%). | Last Observation Carried Forward; Intent to Treat | Posted | Number | percentage of participants | 26 weeks |
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| Secondary | Change in Body Weight | Change in body weight from baseline to week 26 | Intent to Treat | Posted | Least Squares Mean | Standard Error | kg | Baseline, week 26 |
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| Secondary | Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline to week 26 | Last Observation Carried Forward; Intent to Treat | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, week 26 |
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| Secondary | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26 | Last Observation Carried Forward; Intent to Treat | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, week 26 |
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| Secondary | Percentage of Patients With Hypoglycemic Events | Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study | Intent to Treat | Posted | Number | percentage of participants | 26 weeks |
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| Secondary | Change in Rate of Hypoglycemic Events | Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26 | Intent to Treat | Posted | Least Squares Mean | Standard Error | events per 30 days per patient | Baseline, week 26 |
|
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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 | Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks) | 8 | 226 | ||||
| EG001 | Insulin Glargine Arm | Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level) | 10 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Angioneurotic edema | Skin and subcutaneous tissue disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Coronary artery atherosclerosis | Cardiac disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Dermatofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA7.0/11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA7.0/11.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA7.0/11.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Ohman, Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| 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 |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| 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 |
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| Male |
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