A Phase 2 interventional study of Yohimbine in Type 2 Diabetes, sponsored by Anders Rosengren, MD PhD. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-01-09.
Sponsored by Anders Rosengren, MD PhD · Phase 2, Interventional, and Treatment
The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.
We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Anders Rosengren, MD PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo first, then yohimbine
Drug: Yohimbine
Yohimbine first then placebo
Drug: Yohimbine
Yohimbine capsule
Insulin Secretion
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.
Time frame: 30 minutes after oral glucose
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.
Time frame: 30 minutes after oral glucose
| Milestone | Placebo First Then Yohimbine | Yohimbine First Then Placebo |
|---|---|---|
| Started | 25 | 25 |
| Completed | 24 | 25 |
| Not completed | 1 | 0 |
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.
| % increase of Ins30 | Placebo | Yohimbine |
|---|---|---|
| Insulin Secretion | 5 (-13 to 20) | 29 (5 to 52) |
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.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/49 (0%) | 0/49 (0%) |
| Yohimbine | — | 1/49 (2%) | 6/49 (12.2%) |
| Event | Placebo | Yohimbine |
|---|---|---|
| Transitory ischemic attackVascular disorders | 0/49 | 1/49 |
| AnxietyPsychiatric disorders | 0/49 | 1/49 |
| Event | Placebo | Yohimbine |
|---|---|---|
| AnxietyPsychiatric disorders | 0/49 | 6/49 |
| Age, Continuous(years) | Placebo First Then Yohimbine | Yohimbine First Then Yohimbine | Total |
|---|---|---|---|
| Mean | 61 ± 8 | 60 ± 7 | 60 ± 8 |
| Age, Categorical(Participants) | Placebo First Then Yohimbine | Yohimbine First Then Yohimbine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 4 | 4 | 8 |
| Sex: Female, Male(Participants) | Placebo First Then Yohimbine | Yohimbine First Then Yohimbine | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 20 | 22 | 42 |
| Region of Enrollment(participants) | Placebo First Then Yohimbine | Yohimbine First Then Yohimbine | Total |
|---|---|---|---|
| Sweden | 25 | 25 | 50 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Anders Rosengren, MD PhD