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Effect of bromocriptine-QR on glycemic control in subjects with uncontrolled hyperglycemia on one or two oral
Aaron I Vinik1, Anthony H Cincotta, Richard E Scranton
1Strelitz Diabetes Center and Neuroendocrine Unit, Norfolk, Virginia, USA.
Objective:
To investigate the effect of Bromocriptine-QR on glycemic control in patients with type 2 diabetes whose glycemia is poorly controlled on one or two oral anti-diabetes agents.
Methods:
Five hundred fifteen Type 2 Diabetes Mellitus (T2DM) subjects (ages 18 to 80 and average body mass index [BMI] of 32.7) with baseline HbA1c ≥ 7.5 and on one or two oral anti-diabetes (OAD) medications (metformin, sulfonylurea, and/or thiazolidinediones) were randomized 2:1 to bromocriptine-QR (1.6 to 4.8 mg/day) or placebo for a 24 week treatment period. Study investigators were allowed to adjust, if necessary, subject anti-diabetes medications during the study to attempt to achieve glycemic control in case of glycemic deterioration. The impact of bromocriptine-QR treatment intervention on glycemic control was assessed in subjects on any one or two OADs (ALL treatment category) (N = 515), or on metformin with or without another OAD (Met/OAD treatment category) (N = 356), or on metformin plus a sulfonylurea (Met/SU treatment category) (N = 245) 1) by examining the between group difference in change from baseline a) concomitant OAD medication changes during the study, and b) HbA1c and 2) by determining the odds of reaching HbA1c of ≤ 7.0% on bromocriptine-QR versus placebo.
Results:
Significantly more patients (approximately 1.5 to 2-fold more; P<.05) intensified concomitant anti-diabetes medication therapy during the study in the placebo versus the bromocriptine-QR arm. In subjects that did not change the intensity of the baseline diabetes therapy (72%), and that were on any one or two OADs (ALL), or on metformin with or without another OAD (Met/OAD), or on metformin plus sulfonylurea (Met/SU), the HbA1c change for bromocriptine-QR versus placebo was -0.47 versus +0.22 (between group delta of -0.69, P<.0001), -0.55 versus +0.26 (between group delta of -0.81, P<.0001) and -0.63 versus +0.20 (between group delta of -0.83, P<.0001) respectively, after 24 weeks on therapy. The odds ratio of reaching HbA1c of ≤ 7.0% was 6.50, 12.03 and 11.45 (P<.0002) for these three groups, respectively.
Conclusion:
In T2DM subjects whose hyperglycemia is poorly controlled on one or two oral agents, bromocriptine-QR therapy for 24 weeks can provide significant added improvement in glycemic control relative to adding placebo.
Insights
Bromocriptine-QR significantly improved glycemic control in type 2 diabetes patients inadequately managed with oral agents. This study found bromocriptine-QR added to existing therapies led to better HbA1c levels compared to placebo.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Pharmacology
Background:
- Type 2 diabetes mellitus (T2DM) affects millions globally, often requiring complex management strategies.
- Poor glycemic control in T2DM is linked to severe long-term complications.
- Oral anti-diabetes agents (OADs) are foundational, but many patients need additional therapies.
Purpose of the Study:
- To evaluate the efficacy of bromocriptine-QR as an add-on therapy for T2DM.
- To assess its impact on glycemic control in patients with suboptimal response to OADs.
- To compare bromocriptine-QR versus placebo in improving HbA1c levels.
Main Methods:
- A 24-week, randomized, double-blind, placebo-controlled trial.
- 515 T2DM patients with HbA1c ≥ 7.5% on 1-2 OADs were randomized (2:1) to bromocriptine-QR or placebo.
- Glycemic control was assessed by HbA1c changes and the odds of achieving HbA1c ≤ 7.0%.
Main Results:
- Bromocriptine-QR treatment resulted in significantly greater HbA1c reductions compared to placebo across all analyzed subgroups.
- Patients on bromocriptine-QR had a 1.5 to 2-fold higher likelihood of achieving target HbA1c levels (≤ 7.0%).
- Fewer patients in the bromocriptine-QR arm required intensification of concomitant anti-diabetes medication.
Conclusions:
- Bromocriptine-QR offers a significant therapeutic benefit for T2DM patients with poor glycemic control on OADs.
- It provides added glycemic improvement beyond existing oral therapies.
- This suggests bromocriptine-QR is a valuable option for enhancing diabetes management.
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