Trial Outcomes & Findings for QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes (NCT NCT01474018)

Results Overview

Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Baseline - 24 weeks

Results posted on

2019-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin + Insulin 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling. Study has completed	QR-Bromocriptine +Metformin+Insulin study drug add-on the usual therapy QR-bromocriptine: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.
Overall Study STARTED	5	10
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Metformin + Insulin 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling. Study has completed	QR-Bromocriptine +Metformin+Insulin study drug add-on the usual therapy QR-bromocriptine: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin + Insulin n=5 Participants 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling. No Change	QR-Bromocriptine +Metformin+Insulin n=10 Participants study drug add-on the usual therapy QR-bromocriptine: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.	Total n=15 Participants Total of all reporting groups
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	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 3 • n=5 Participants	54 years STANDARD_DEVIATION 3 • n=7 Participants	50 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - 24 weeks

Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin

Outcome measures

Outcome measures
Measure	Metformin + Insulin n=5 Participants 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise / nutrition counseling.	QR-Bromocriptine + Metformin + Insulin n=7 Participants study drug add-on to usual therapy with insulin + metformin + exercise / nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The titration was stopped when the patient reported side effects and the dose was subsequently reduced to the highest tolerable dose at which the side effect did not occur. The patient maintained this dose for the duration of the 24-week treatment period.
Change in A1c	9.74 percent HbA1c Standard Error 0.56	7.98 percent HbA1c Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline - 24 weeks

Change in total daily insulin dose in patients treated with QR-Bromocriptine +metformin +insulin compared to metformin + insulin alone

Outcome measures

Outcome measures
Measure	Metformin + Insulin n=5 Participants 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise / nutrition counseling.	QR-Bromocriptine + Metformin + Insulin n=7 Participants study drug add-on to usual therapy with insulin + metformin + exercise / nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The titration was stopped when the patient reported side effects and the dose was subsequently reduced to the highest tolerable dose at which the side effect did not occur. The patient maintained this dose for the duration of the 24-week treatment period.
Total Daily Insulin Dose	199 units of insulin Standard Error 33	147 units of insulin Standard Error 31

Adverse Events

Metformin + Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

QR-Bromocriptine + Metformin + Insulin

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

Dr. Erin D. Roe

Baylor Endocrine Center

Phone: 214-820-3466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place