Trial Outcomes & Findings for Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant (NCT NCT01593215)

Results Overview

insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

30 minutes after oral glucose

Results posted on

2015-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First Then Yohimbine Placebo first, then 2 weeks washout and then yohimbine	Yohimbine First Then Placebo Yohimbine first, 2 weeks washout and then placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First Then Yohimbine n=25 Participants placebo first Yohimbine: Yohimbine capsule	Yohimbine First Then Yohimbine n=25 Participants Yohimbine first and then placebo	Total n=50 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 8 • n=5 Participants	60 years STANDARD_DEVIATION 7 • n=7 Participants	60 years STANDARD_DEVIATION 8 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Sweden	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after oral glucose

insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants placebo Yohimbine: Yohimbine capsule	Yohimbine n=49 Participants Yohimbine Yohimbine: Yohimbine capsule
Insulin Secretion	5 % increase of Ins30 Interval -13.0 to 20.0	29 % increase of Ins30 Interval 5.0 to 52.0

SECONDARY outcome

Timeframe: 30 minutes after oral glucose

Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Yohimbine

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=49 participants at risk placebo Yohimbine: Yohimbine capsule	Yohimbine n=49 participants at risk Yohimbine Yohimbine: Yohimbine capsule
Vascular disorders Transitory ischemic attack	0.00% 0/49	2.0% 1/49
Psychiatric disorders Anxiety	0.00% 0/49	2.0% 1/49

Other adverse events

Other adverse events
Measure	Placebo n=49 participants at risk placebo Yohimbine: Yohimbine capsule	Yohimbine n=49 participants at risk Yohimbine Yohimbine: Yohimbine capsule
Psychiatric disorders Anxiety	0.00% 0/49	12.2% 6/49 • Number of events 6

Additional Information

Anders Rosengren

RegionSkane

Phone: +4640391169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place