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Vildagliptin Versus Dapagliflozin on Glucagon

Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Vildagliptin (Drug); Dapagliflozin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Lund University

Official(s) and/or principal investigator(s):
Bo Ahren, MD PhD, Principal Investigator, Affiliation: Lund University

Overall contact:
Bo Ahren, MD PhD, Phone: +46462220758, Email: Bo.Ahren@med.lu.se

Summary

The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.

Clinical Details

Official title: Study of Ther Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Glucagon response to meal

Secondary outcome: Incretin hormones

Detailed description: The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. Subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Written consent has been given. 2. Patients with type 2 diabetes treated with a stable dose of metformin during the last three months 3. Age 20-70 years. 4. HbA1c 6. 5-8. 5% (48-67 mmol/mol) at visit 1. 5. Ability to complete the study Exclusion Criteria: 1. Use of other glucose-lowering therapy than metformin within three months prior to visit 1. 2. A history of any secondary forms of diabetes, e. g., Cushing's syndrome and acromegaly. 3. Type 1 diabetes, positive GAD antibodies 4. Estimated glomerular filtration rate <60 ml/min 5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 6. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes. 7. Any history of acute pancreatitis 8. Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. 9. Liver disease such as cirrhosis or chronic active hepatitis 10. History of coronary heart disease or heart failure class III or IV 11. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 12. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study 14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core

Locations and Contacts

Bo Ahren, MD PhD, Phone: +46462220758, Email: Bo.Ahren@med.lu.se

Lund University, Lund 22184, Sweden; Not yet recruiting
Bo Ahren, MD PhD, Phone: +46462220758, Email: Bo.Ahren@med.lu.se
Additional Information

Starting date: October 2015
Last updated: June 17, 2015

Page last updated: August 23, 2015

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