N/A
N=16
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
Type 1 Diabetes · Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01272583 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Glucagon Response to Acute Hypoglycaemia — 1.33; 1.0; 1.33 pmol/L — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sitagliptin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucagon Response to Acute Hypoglycaemia |
120; 125; 120 | 0.98 |
| PRIMARY Glucagon Response to Acute Hypoglycaemia |
120; 125; 120 | 0.98 |
| SECONDARY Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia |
2.000; 43.50; 4.500; 562.2; 555.0; 552.5 | <0.001 sig |
| SECONDARY Epinephrine Response to Acute Hypoglycaemia |
36.1; 32.6; 58.7 | 0.14 |
| SECONDARY Norepinephrine Response to Acute Hypoglycaemia |
70.0; 62.5; 62.3 | 0.22 |
| SECONDARY Growth Hormone Response to Acute Hypoglycaemia |
1299; 261.5; 1406 | 0.01 sig |
| SECONDARY Cortisol Response to Acute Hypoglycaemia |
14480; 13190; 14800 | 0.76 |
| SECONDARY Symptomatic Hormone Responses to Acute Hypoglycaemia. |
1.7; 1.3; 1.5; 2.1; 2.4; 2.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes Mellitus 5-20 years duration
- C-peptide negative
- Willing and able to give written informed consent
Exclusion Criteria
- Impaired awareness of hypoglycaemia
- BMI > 27 kg/m2
- Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy)
- Acute illness within 3 months before the study
- Significant renal impairment (creatinine clearance < 50ml/min)
- Use of beta-adrenoreceptor blockers
- Cardiac history (previous arrhythmia)
- History of epilepsy
Data sourced from ClinicalTrials.gov (NCT01272583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.