The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients
NCT ID: NCT03419624
Last Updated: 2020-03-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
13 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-19
Study Completion Date
2019-08-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a 28-week, multi-center, randomized, double-blind, placebo-controlled trial to study a potential synergistic effect of Dapagliflozin plus Exenatide once-weekly in combination with high-dose intensive insulin therapy compared to Placebo in obese insulin-resistant patients with Type 2 Diabetes mellitus (T2DM) and inadequate glycemic control (HbA1c≥8.0% and ≤ 11.0%).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.
NCT03007329
Steatosis, Liver
Type2 Diabetes
COMPLETED
PHASE4
Evaluation of Dapagliflozin Taken Twice-daily
NCT01217892
Type 2 Diabetes
COMPLETED
PHASE3
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
NCT00673231
Type 2 Diabetes
COMPLETED
PHASE3
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
NCT00831779
Type 2 Diabetes Mellitus
COMPLETED
PHASE2
A Phase IV Study in Drug-Naive Patients With T2DM in China
NCT03344341
Type 2 Diabetes Mellitus
TERMINATED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this proof-of-concept study the potential of treatment with Dapagliflozin plus Exenatide added to high-dose intensive insulin therapy compared to Placebo added to high-dose intensive insulin with active insulin up-titration for change in HbA1c from baseline to week 28 shall be explored and generate initial data on the primary outcome. We hypothesize that SGLT-2 inhibition and GLP-1 receptor agonism may be a rational combination therapy that addresses a broad range of pathophysiological defects associated with T2DM in obesity and may reduce HbA1c levels in patients with severe insulin resistance. In a third treatment arm, patients will be treated with Exenatide monotherapy added to high-dose intensive Insulin therapy to study additive effects of Dapagliflozin and Exenatide.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Obesity
Diabetes Mellitus, Type 2
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dapagliflozin plus Exenatide
Dapagliflozin (10mg orally once daily) plus Exenatide (2mg subcutaneous once-weekly injection) as add-on to high-dose intensive insulin therapy
Group Type
EXPERIMENTAL
Dapagliflozin 10mg
Intervention Type
DRUG
Dapagliflozin 10 mg tablet once daily
Exenatide 2 mg [Bydureon]
Intervention Type
DRUG
Exenatide 2 mg injection once weekly
Insulin
Intervention Type
DRUG
daily Insulin injections
Metformin, if taken before
Intervention Type
DRUG
If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.
Placebo plus Placebo
Placebo (film-coated tablet once daily) plus Placebo (subcutaneous once-weekly injection) as add-on to high-dose intensive insulin therapy
Group Type
PLACEBO_COMPARATOR
Placebo Oral Tablet
Intervention Type
DRUG
Placebo oral tablet once daily
Placebo injection
Intervention Type
DRUG
Placebo injection once weekly
Insulin
Intervention Type
DRUG
daily Insulin injections
Metformin, if taken before
Intervention Type
DRUG
If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.
Placebo plus Exenatide
Placebo (film-coated tablet once daily) plus Exenatide (2mg subcutaneous once- weekly injection) as add-on to high dose intensive insulin therapy
Group Type
ACTIVE_COMPARATOR
Exenatide 2 mg [Bydureon]
Intervention Type
DRUG
Exenatide 2 mg injection once weekly
Placebo Oral Tablet
Intervention Type
DRUG
Placebo oral tablet once daily
Insulin
Intervention Type
DRUG
daily Insulin injections
Metformin, if taken before
Intervention Type
DRUG
If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dapagliflozin 10mg
Dapagliflozin 10 mg tablet once daily
Intervention Type
DRUG
Exenatide 2 mg [Bydureon]
Exenatide 2 mg injection once weekly
Intervention Type
DRUG
Placebo Oral Tablet
Placebo oral tablet once daily
Intervention Type
DRUG
Placebo injection
Placebo injection once weekly
Intervention Type
DRUG
Insulin
daily Insulin injections
Intervention Type
DRUG
Metformin, if taken before
If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Informed Consent can be obtained prior to any study procedures.
2. Patient is able to read, understand and sign the Informed Consent.
3. HbA1c ≥ 8.0% and ≤ 11.0% based on laboratory results
4. Currently treated with a stable TDID ≥ 80 U at least 3 months prior to enrolment
5. Patients who are receiving metformin must be on a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
6. BMI of ≥ 30 kg/m2 at enrolment
7. Male or female and ≥18 and ≤75 years old at time of informed consent
8. For female patients:
* Not breastfeeding.
* Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[βhCG\]) at Visit 0 (Screening) and Visit 1 (randomization) -not applicable to hysterectomized and post-menopausal females.
* If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives \[pills, vaginal rings, or patches\], some intrauterine contraceptive devices \[levonorgestrel-releasing or copper-T\], tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study. As applicable, all methods must be in effect prior to receiving the first dose of study medication.
* Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication.
9. Patients who are receiving the following medications must be on a stable treatment regimen for a minimum of 2 months prior to Visit 0 (Screening):
* Antihypertensive agents
* Thyroid replacement therapy
* Antidepressant agents
2. Patient is able to read, understand and sign the Informed Consent.
3. HbA1c ≥ 8.0% and ≤ 11.0% based on laboratory results
4. Currently treated with a stable TDID ≥ 80 U at least 3 months prior to enrolment
5. Patients who are receiving metformin must be on a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
6. BMI of ≥ 30 kg/m2 at enrolment
7. Male or female and ≥18 and ≤75 years old at time of informed consent
8. For female patients:
* Not breastfeeding.
* Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[βhCG\]) at Visit 0 (Screening) and Visit 1 (randomization) -not applicable to hysterectomized and post-menopausal females.
* If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives \[pills, vaginal rings, or patches\], some intrauterine contraceptive devices \[levonorgestrel-releasing or copper-T\], tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study. As applicable, all methods must be in effect prior to receiving the first dose of study medication.
* Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication.
9. Patients who are receiving the following medications must be on a stable treatment regimen for a minimum of 2 months prior to Visit 0 (Screening):
* Antihypertensive agents
* Thyroid replacement therapy
* Antidepressant agents
Exclusion Criteria
1. Diagnosis of Type 1 Diabetes
2. History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced Type 2 diabetes
3. Patients with significant thyroid disease
4. Patients with history of acute or chronic pancreatitis
5. Clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure
6. Presence of history of severe congestive heart failure (NYHA III and IV)
7. Creatinin-Clearance of \< 60 ml/min based on local laboratory results
8. Concomitant medication with loop diuretics
9. Patients who, as judged by the investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety (including e.g. patients with a history of Diabetes insipidus)
10. Pregnant women
11. Administration of any other antidiabetic therapy, other than insulin (see inclusion criterion no.4 and 5) and metformin with a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
12. History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at Visit 0 (Screening).
13. History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
14. History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
15. Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or total bilirubin (TB) \>2 mg/dL (\>34.2 μmol/L) (patients with TB \>2 mg/dL \[\>34.2 μmol/L\] and documented Gilbert's syndrome will be allowed to participate).
16. Known history of hepatotoxicity with any medication
17. Known history of severe hepatobiliary disease.
18. Positive serological test for hepatitis B or hepatitis C.
19. Known or suspected human immunodeficiency virus (HIV) infection.
20. History of organ transplantation.
21. Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2.
22. Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 0 (Screening).
23. Hemoglobinopathy, hemolytic anemia, or chronic anemia (haemoglobin concentration \<11.5 g/dL \[115 g/L\] for males, \<10.5 g/dL \[105 g/L\] for females) or any other condition known to interfere with the HbA1c methodology.
24. Patients with abnormal test results of hematocrit (hematocrit \> 50% for men; hematocrit \> 47% for women)
25. Has donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study.
26. Has donated plasma within 7 days prior to first dose of study medication.
27. Any exposure to Exenatide (including BYETTA®, BYDUREON, or exenatide suspension).
28. Any exposure to Dapagliflozin or any SGLT-2 inhibitor.
29. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
* Any DPP-4 inhibitor within 3 months prior to Visit 0 (Screening).
* Any GLP-1 analog within 1 year prior to Visit 0 (Screening).
* Systemic corticosteroids within 3 months prior to Visit 0 (Screening) by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR) steroids known to have a high rate of systemic absorption. For examples of excluded steroids, refer to Section 7.7.
* Prescription or over-the-counter weight loss medications within 3 months prior to Visit 0 (Screening).
2. History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced Type 2 diabetes
3. Patients with significant thyroid disease
4. Patients with history of acute or chronic pancreatitis
5. Clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure
6. Presence of history of severe congestive heart failure (NYHA III and IV)
7. Creatinin-Clearance of \< 60 ml/min based on local laboratory results
8. Concomitant medication with loop diuretics
9. Patients who, as judged by the investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety (including e.g. patients with a history of Diabetes insipidus)
10. Pregnant women
11. Administration of any other antidiabetic therapy, other than insulin (see inclusion criterion no.4 and 5) and metformin with a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
12. History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at Visit 0 (Screening).
13. History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
14. History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
15. Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or total bilirubin (TB) \>2 mg/dL (\>34.2 μmol/L) (patients with TB \>2 mg/dL \[\>34.2 μmol/L\] and documented Gilbert's syndrome will be allowed to participate).
16. Known history of hepatotoxicity with any medication
17. Known history of severe hepatobiliary disease.
18. Positive serological test for hepatitis B or hepatitis C.
19. Known or suspected human immunodeficiency virus (HIV) infection.
20. History of organ transplantation.
21. Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2.
22. Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 0 (Screening).
23. Hemoglobinopathy, hemolytic anemia, or chronic anemia (haemoglobin concentration \<11.5 g/dL \[115 g/L\] for males, \<10.5 g/dL \[105 g/L\] for females) or any other condition known to interfere with the HbA1c methodology.
24. Patients with abnormal test results of hematocrit (hematocrit \> 50% for men; hematocrit \> 47% for women)
25. Has donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study.
26. Has donated plasma within 7 days prior to first dose of study medication.
27. Any exposure to Exenatide (including BYETTA®, BYDUREON, or exenatide suspension).
28. Any exposure to Dapagliflozin or any SGLT-2 inhibitor.
29. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
* Any DPP-4 inhibitor within 3 months prior to Visit 0 (Screening).
* Any GLP-1 analog within 1 year prior to Visit 0 (Screening).
* Systemic corticosteroids within 3 months prior to Visit 0 (Screening) by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR) steroids known to have a high rate of systemic absorption. For examples of excluded steroids, refer to Section 7.7.
* Prescription or over-the-counter weight loss medications within 3 months prior to Visit 0 (Screening).
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Sponsor Role
collaborator
Universitätsklinikum Hamburg-Eppendorf
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens Aberle, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabeteszentrum Oldenburg
Oldenburg, Lower Saxony, Germany
Site Status
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Site Status
Diabetologische Schwerpunktpraxis Harburg
Hamburg, , Germany
Site Status
Gemeinschaftspraxis für Innere Medizin und Diabetologie
Hamburg, , Germany
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Germany
References
Explore related publications, articles, or registry entries linked to this study.
Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context. 2015 Jul 9;4:212283. doi: 10.7573/dic.212283. eCollection 2015.
Reference Type
BACKGROUND
Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):405-15. doi: 10.7326/0003-4819-156-6-201203200-00003.
Reference Type
BACKGROUND
Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.
Reference Type
BACKGROUND
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
Reference Type
BACKGROUND
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012 Jun;55(6):1577-96. doi: 10.1007/s00125-012-2534-0. Epub 2012 Apr 20. No abstract available.
Reference Type
BACKGROUND
Tatarkiewicz K, Polizzi C, Villescaz C, D'Souza LJ, Wang Y, Janssen S, Parkes DG. Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice. Diabetes Obes Metab. 2014 Apr;16(4):376-80. doi: 10.1111/dom.12237. Epub 2013 Dec 9.
Reference Type
BACKGROUND
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008 Jan;31(1):173-5. doi: 10.2337/dc08-9016. No abstract available.
Reference Type
BACKGROUND
Wangnoo SK, Sethi B, Sahay RK, John M, Ghosal S, Sharma SK. Treat-to-target trials in diabetes. Indian J Endocrinol Metab. 2014 Mar;18(2):166-74. doi: 10.4103/2230-8210.129106.
Reference Type
BACKGROUND
Holman R. Metformin as first choice in oral diabetes treatment: the UKPDS experience. Journ Annu Diabetol Hotel Dieu. 2007:13-20.
Reference Type
BACKGROUND
Blevins T, Pullman J, Malloy J, Yan P, Taylor K, Schulteis C, Trautmann M, Porter L. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 May;96(5):1301-10. doi: 10.1210/jc.2010-2081. Epub 2011 Feb 9.
Reference Type
BACKGROUND
Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.
Reference Type
BACKGROUND
Sharma S, Jain S. Prevalence of Obesity among Type-2 Diabetics. J Hum Ecol 2009;25:31-5.
Reference Type
BACKGROUND
Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002 Feb;25(2):358-63. doi: 10.2337/diacare.25.2.358.
Reference Type
BACKGROUND
2012. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus n.d. ema.europa.eu.
Reference Type
BACKGROUND
Anderson SL. Dapagliflozin efficacy and safety: a perspective review. Ther Adv Drug Saf. 2014 Dec;5(6):242-54. doi: 10.1177/2042098614551938.
Reference Type
BACKGROUND
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes 2016. www.ema.europe.eu.
Reference Type
BACKGROUND
Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16.
Reference Type
BACKGROUND
FDA approves Farxiga to treat type 2 diabetes. 2014 n.d. fda.gov.
Reference Type
BACKGROUND
FDA Approves Bydureon Pen. 2014 n.d. drugs.com.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UKE-DapEx-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes
NCT03444584
COMPLETED
PHASE2
Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
NCT02157298
COMPLETED
PHASE4
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
NCT02429258
COMPLETED
PHASE4
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01646320
COMPLETED
PHASE3
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
NCT01042977
COMPLETED
PHASE3
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
NCT00972244
COMPLETED
PHASE2
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
NCT00859898
COMPLETED
PHASE3
Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone
NCT01257412
SUSPENDED
PHASE3
The Effect of a SGLT2 Inhibitor on Glucose Flux, Lipolysis and Exercise in Type 2 Diabetes
NCT04219124
COMPLETED
PHASE4
Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice
NCT02719132
WITHDRAWN
PHASE4
Phase III Insulin Add-On Asia Regional Program - ST
NCT02096705
COMPLETED
PHASE3
The Effects of Dapagliflozin in Normal Clinical Practice in T2D
NCT05418946
UNKNOWN
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
NCT00701935
TERMINATED
PHASE2
Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
NCT04356742
COMPLETED
PHASE3
Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus
NCT04195243
UNKNOWN
PHASE3
Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
NCT01156246
COMPLETED
PHASE1
A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy
NCT03499704
UNKNOWN
PHASE4
Effect of Anti-diabetic Drugs on Glycemic Variability
NCT02925559
COMPLETED
PHASE4
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
NCT01392677
COMPLETED
PHASE3
A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes
NCT02765204
COMPLETED
PHASE4
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
NCT00099320
COMPLETED
PHASE3
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
NCT01498185
COMPLETED
PHASE2
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
NCT01294423
COMPLETED
PHASE3
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
NCT00736879
COMPLETED
PHASE3