Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery

Short name DARE

NCTNCT01272583Other idDARE_2010

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 16 participants (actual)
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
Design: Randomized · Triple masking
Countries: 1 country
Netherlands
Start: Mar 2011
Primary completion: Jun 2012
Completion: Oct 2012
First posted: 10 Jan 2011 (estimated)
Last update posted: 14 Mar 2014 (estimated)
Conditions: Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

N/A
DARE
NCT01272583
Mar 2011 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

Interventions

SitagliptinDrug
PlaceboDrug

Arms2

Other
Sequence A (sitagliptin→placebo)
Cross-over, both arms reveived the same intervention in different order.
Other
Sequence B (placebo→sitagliptin)
Cross-over, both arms reveived the same intervention in different order.

Primary outcomes2

Outcomes the sponsor listed as primary.

Glucagon Response to Acute Hypoglycaemia
Time frame · Change from initialisation phase to 40 minutes after onset of hypoglycaemia
Registry description
Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia
Glucagon Response to Acute Hypoglycaemia
Time frame · 0, 10, 20 and 40 minutes
Registry description
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.

Secondary outcomes(6)

Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia
Time frame · 0, 10, 20, 40 minutes
Registry description
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.
Epinephrine Response to Acute Hypoglycaemia
Time frame · 0, 10, 20, 40 minutes
Registry description
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.
Norepinephrine Response to Acute Hypoglycaemia
Time frame · 0, 10, 20, 40 minutes
Registry description
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.
Growth Hormone Response to Acute Hypoglycaemia
Time frame · 0, 10, 20, 40 minutes
Registry description
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.
Cortisol Response to Acute Hypoglycaemia
Time frame · 0, 10, 20, 40 minutes
Registry description
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.
Symptomatic Hormone Responses to Acute Hypoglycaemia.
Time frame · Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Change from initialisation phase to 40 minutes after onset of hypoglycaemia

Glucagon Response to Acute Hypoglycaemia

Group	Value (pmol/L)
Baseline	1.33
Sitagliptin Treatment	1.0
Placebo	1.33

Primary outcomeMedian· 0, 10, 20 and 40 minutes