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Clinical Trial Details

Trial ID: L6491
Source ID: NCT01272583
Associated Drug: Sitagliptin
Title: Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
Acronym: DARE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01272583/results
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: Sitagliptin|DRUG: Placebo
Outcome Measures: Primary: Glucagon Response to Acute Hypoglycaemia, Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia, Change from initialisation phase to 40 minutes after onset of hypoglycaemia|Glucagon Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20 and 40 minutes | Secondary: Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20, 40 minutes|Epinephrine Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20, 40 minutes|Norepinephrine Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20, 40 minutes|Growth Hormone Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20, 40 minutes|Cortisol Response to Acute Hypoglycaemia, Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method., 0, 10, 20, 40 minutes|Symptomatic Hormone Responses to Acute Hypoglycaemia., The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable., Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia
Sponsor/Collaborators: Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Collaborators: Merck Sharp & Dohme LLC
Gender: MALE
Age: ADULT
Phases:
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose:
Start Date: 2011-03
Completion Date: 2012-10
Results First Posted: 2014-02-17
Last Update Posted: 2014-03-14
Locations: Academic Medical Center, Amsterdam, Noord Holland, 1100DD, Netherlands
URL: https://clinicaltrials.gov/show/NCT01272583