Trial Outcomes & Findings for Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery (NCT NCT01272583)
NCT ID: NCT01272583
Last Updated: 2014-03-14
Results Overview
Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia
COMPLETED
NA
16 participants
Change from initialisation phase to 40 minutes after onset of hypoglycaemia
2014-03-14
Participant Flow
Participants came to the Academic Medical Center in Amsterdam for a screening visit to determine eligibility for the study.
Patients were excluded if they were found to have impaired awareness of hypoglycaemia, had a history of seizures, cardiac arrhythmia (or used beta-adrenoreceptor blockers) and/or acute infection in the 12 weeks before the study, or evidence of severe diabetes complications (autonomic neuropathy, nephropathy or proliferative retinopathy).
Participant milestones
| Measure |
Sequence A (Sitagliptin→Placebo)
Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks
|
Sequence B (Placebo→Sitagliptin)
Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
Baseline characteristics by cohort
| Measure |
Sequence A (Sitagliptin→Placebo)
n=8 Participants
Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks
|
Sequence B (Placebo→Sitagliptin)
n=8 Participants
Cross-over, both arms reveived the same intervention in different order.
Sitagliptin : 100 mg once daily for six weeks
Placebo : placebo, once daily for six weeks
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
INTER_QUARTILE_RANGE 26.3-39 • n=99 Participants
|
33.5 years
INTER_QUARTILE_RANGE 27.8-40.8 • n=107 Participants
|
31.5 years
INTER_QUARTILE_RANGE 27.0-40.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from initialisation phase to 40 minutes after onset of hypoglycaemiaChange in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Glucagon Response to Acute Hypoglycaemia
|
1.33 pmol/L
Interval -0.67 to 2.67
|
1.0 pmol/L
Interval -0.67 to 2.67
|
1.33 pmol/L
Interval -1.0 to 2.33
|
PRIMARY outcome
Timeframe: 0, 10, 20 and 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Glucagon Response to Acute Hypoglycaemia
|
120 pmol*minutes/L
Interval 90.0 to 215.0
|
125 pmol*minutes/L
Interval 20.0 to 215.0
|
120 pmol*minutes/L
Interval 85.0 to 200.0
|
SECONDARY outcome
Timeframe: 0, 10, 20, 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia
GIP total
|
302.5 pmol*minutes/L
Interval 201.3 to 436.3
|
285.0 pmol*minutes/L
Interval 160.0 to 367.5
|
342.5 pmol*minutes/L
Interval 238.8 to 497.5
|
|
Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia
GLP-1 intact
|
2.000 pmol*minutes/L
Interval 0.0 to 15.5
|
43.50 pmol*minutes/L
Interval 12.0 to 81.5
|
4.500 pmol*minutes/L
Interval 0.0 to 21.0
|
|
Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia
GLP-1 total
|
562.2 pmol*minutes/L
Interval 435.0 to 623.8
|
555.0 pmol*minutes/L
Interval 450.0 to 611.3
|
552.5 pmol*minutes/L
Interval 433.8 to 596.3
|
|
Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia
GIP intact
|
455.0 pmol*minutes/L
Interval 361.3 to 513.8
|
490.0 pmol*minutes/L
Interval 461.3 to 630.0
|
452.5 pmol*minutes/L
Interval 435.0 to 532.5
|
SECONDARY outcome
Timeframe: 0, 10, 20, 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Epinephrine Response to Acute Hypoglycaemia
|
36.1 nmol*minutes/L
Interval 31.1 to 62.5
|
32.6 nmol*minutes/L
Interval 17.0 to 65.0
|
58.7 nmol*minutes/L
Interval 34.8 to 71.3
|
SECONDARY outcome
Timeframe: 0, 10, 20, 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Norepinephrine Response to Acute Hypoglycaemia
|
70.0 nmol*minutes/L
Interval 52.5 to 88.1
|
62.5 nmol*minutes/L
Interval 44.9 to 73.0
|
62.3 nmol*minutes/L
Interval 49.1 to 72.5
|
SECONDARY outcome
Timeframe: 0, 10, 20, 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Growth Hormone Response to Acute Hypoglycaemia
|
1299 mU*minutes/L
Interval 313.5 to 2560.0
|
261.5 mU*minutes/L
Interval 47.0 to 1499.0
|
1406 mU*minutes/L
Interval 781.0 to 2626.0
|
SECONDARY outcome
Timeframe: 0, 10, 20, 40 minutesArea 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Cortisol Response to Acute Hypoglycaemia
|
14480 mU*minutes/L
Interval 11300.0 to 17180.0
|
13190 mU*minutes/L
Interval 10920.0 to 18680.0
|
14800 mU*minutes/L
Interval 8985.0 to 19160.0
|
SECONDARY outcome
Timeframe: Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemiaThe 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.
Outcome measures
| Measure |
Baseline
n=16 Participants
|
Sitagliptin Treatment
n=16 Participants
|
Placebo
n=16 Participants
|
|---|---|---|---|
|
Symptomatic Hormone Responses to Acute Hypoglycaemia.
Autonomic symptoms score
|
1.7 units on a scale
Interval 1.7 to 2.9
|
1.3 units on a scale
Interval 1.0 to 2.6
|
1.5 units on a scale
Interval 1.0 to 2.2
|
|
Symptomatic Hormone Responses to Acute Hypoglycaemia.
Neurologic symptoms score
|
2.1 units on a scale
Interval 1.7 to 3.4
|
2.4 units on a scale
Interval 1.7 to 3.8
|
2.1 units on a scale
Interval 1.5 to 3.3
|
Adverse Events
Baseline
Sitagliptin Treatment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60