Trial Outcomes & Findings for Pantoprazole on Insulin Secretion in Diabetes (NCT NCT01541735)

Results Overview

The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

14 participants

Primary outcome timeframe

Change from Baseline at 45 days. (plus or minus 3 days)

Results posted on

2014-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Pantoprazole The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days	Placebo Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pantoprazole on Insulin Secretion in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pantoprazole n=7 Participants The pantoprazole will be administered in 40mg capsules	Placebo n=7 Participants Placebo of calcined magnesia, capsules	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	49.8 years STANDARD_DEVIATION 7.1 • n=99 Participants	46.2 years STANDARD_DEVIATION 9.6 • n=107 Participants	48.0 years STANDARD_DEVIATION 8.39 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment Mexico	7 participants n=99 Participants	7 participants n=107 Participants	14 participants n=206 Participants

PRIMARY outcome

Timeframe: Change from Baseline at 45 days. (plus or minus 3 days)

Population: The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial

The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.

Outcome measures

Outcome measures
Measure	Pantoprazole n=7 Participants The pantoprazole will be administered in 40mg capsules	Placebo n=7 Participants Placebo of calcined magnesia, capsules
First Phase of Insulin Secretion	13.8 µU/ml Standard Deviation 5.5	15.9 µU/ml Standard Deviation 9.3

PRIMARY outcome

Timeframe: Baseline and 45 day

Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)

Outcome measures

Outcome measures
Measure	Pantoprazole n=7 Participants The pantoprazole will be administered in 40mg capsules	Placebo n=7 Participants Placebo of calcined magnesia, capsules
Second Phase of Insulin Secretion	35.9 µU/ml Standard Deviation 21.2	38.4 µU/ml Standard Deviation 30.1

PRIMARY outcome

Timeframe: Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)

The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion

Outcome measures

Outcome measures
Measure	Pantoprazole n=7 Participants The pantoprazole will be administered in 40mg capsules	Placebo n=7 Participants Placebo of calcined magnesia, capsules
Total Insulin Secretion	29.0 µU/ml Standard Deviation 15.8	31.5 µU/ml Standard Deviation 23.4

SECONDARY outcome

Timeframe: Change from Baseline in glycated hemoglobin A1C at 45 day.

Outcome measures

Outcome measures
Measure	Pantoprazole n=7 Participants The pantoprazole will be administered in 40mg capsules	Placebo n=7 Participants Placebo of calcined magnesia, capsules
Glycated Hemoglobin A1C	7.5 percentage Standard Deviation .38	7.8 percentage Standard Deviation .45

Adverse Events

Pantoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

PhD. Manuel González Ortiz

Instituto Mexicano del Seguro Social

Phone: 33 36176000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place