Trial Outcomes & Findings for Exeantide in Type 2 Diabetes on Insulin (NCT NCT01154933)

Results Overview

To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

after 24 hours fast at baseline and 12 weeks

Results posted on

2022-10-06

Participant Flow

The exenatide 10mcg group started on 5mcg for a single dose study (samples collected were at 0, 2, 4, and 6 hours)

Participant milestones

Participant milestones
Measure	Exenatide Period 1 = 5 mcg Period 2 = 10 mcg	Placebo placebo placebo: saline sq
Exenatide 5 mcg STARTED	12	12
Exenatide 5 mcg COMPLETED	12	12
Exenatide 5 mcg NOT COMPLETED	0	0
Exenatide 10 mcg STARTED	12	12
Exenatide 10 mcg COMPLETED	12	12
Exenatide 10 mcg NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exenatide 10 mcg n=12 Participants exenatide 5mcg and then exenatide 10 mcg	Placebo n=12 Participants placebo placebo: saline sq	Total n=24 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 3 • n=12 Participants	54 years STANDARD_DEVIATION 4 • n=12 Participants	55 years STANDARD_DEVIATION 3 • n=24 Participants
Sex/Gender, Customized Sex/Gender Baseline	—	—	0 Participants Data was not collected
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	39.8 kg/m² STANDARD_DEVIATION 2 • n=12 Participants	39.1 kg/m² STANDARD_DEVIATION 1.6 • n=12 Participants	39.5 kg/m² STANDARD_DEVIATION 1.8 • n=24 Participants
HbA1c	8.6 % STANDARD_DEVIATION 0.4 • n=12 Participants	8.5 % STANDARD_DEVIATION 0.3 • n=12 Participants	8.55 % STANDARD_DEVIATION 0.4 • n=24 Participants
Fasting Blood Glucose	139 mg/dl STANDARD_DEVIATION 17 • n=12 Participants	128 mg/dl STANDARD_DEVIATION 13 • n=12 Participants	133 mg/dl STANDARD_DEVIATION 15 • n=24 Participants
FFA	0.69 mM STANDARD_DEVIATION 0.07 • n=12 Participants	0.64 mM STANDARD_DEVIATION 0.08 • n=12 Participants	0.66 mM STANDARD_DEVIATION 0.08 • n=24 Participants

PRIMARY outcome

Timeframe: after 24 hours fast at baseline and 12 weeks

To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.

Outcome measures

Outcome measures
Measure	Exenatide 10 mcg n=12 Participants exenatide 10 mcg exenatide 10 mcg: exenatide 10 mcg	Placebo n=12 Participants placebo placebo: saline sq
Fasting Insulin At Baseline	12.7 μU/mL Standard Error 2.8	13.1 μU/mL Standard Error 3.1
Fasting Insulin At 12 weeks	16.4 μU/mL Standard Error 3.2	13.9 μU/mL Standard Error 5.9

SECONDARY outcome

Timeframe: value at 12 weeks minus value at baseline

To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients

Outcome measures

Outcome measures
Measure	Exenatide 10 mcg n=12 Participants exenatide 10 mcg exenatide 10 mcg: exenatide 10 mcg	Placebo n=12 Participants placebo placebo: saline sq
Weight	0 lbs Standard Error 20	3 lbs Standard Error 18

SECONDARY outcome

Timeframe: value at 12 weeks minus value at baseline

To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.

Outcome measures

Outcome measures
Measure	Exenatide 10 mcg n=12 Participants exenatide 10 mcg exenatide 10 mcg: exenatide 10 mcg	Placebo n=12 Participants placebo placebo: saline sq
HbA1c	-1.2 percent Standard Error 0.5	-0.5 percent Standard Error 0.3

SECONDARY outcome

Timeframe: measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline

Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group

Outcome measures

Outcome measures
Measure	Exenatide 10 mcg n=12 Participants exenatide 10 mcg exenatide 10 mcg: exenatide 10 mcg	Placebo n=12 Participants placebo placebo: saline sq
Intranuclear NFκB Binding Activity	26 % ratio of NFKB/Oct-1 Standard Error 7	0 % ratio of NFKB/Oct-1 Standard Error 7

Adverse Events

Exenatide 5mcg Then Exenatide 10 mcg

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

Paresh Dandona

State University of NY at Buffalo

Phone: 7165351850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place