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
|