New Weight Loss Medication May Help Obese Type 2 Diabetes Patients Meet Diabetes Goals

The CONQUER study was a 56-week, randomized study that involved subjects who had a BMI ≥ 45 and ≥ 2 weight-related comorbidities.  Some subjects were treated with extended-release phentermine/topiramate (PHEN/TPM ER), and this was compared to results with a placebo; all subjects received lifestyle counseling and were managed to standard of care for comorbidities.

After the CONQUER study ended, an analysis was done of the patients with type 2 diabetes who had participated in the study.¹  They were evaluated to see if they met certain diabetes management goals by the end of the study.  There were 2 sets of composite goals:

• Composite Goals A (CG-A)
  • Weight loss > 5%
  • A1c < 6.5%
  • Systolic blood pressure (SBP) < 140 mmHg
• Composite Goals B (CG-B)
  • Weight loss > 10%
  • A1c < 6.5%
  • Systolic blood pressure < 140 mmHg

Please note that the only difference in the Composite Goals A and B is the level of weight loss.  Both Composite Goals A and B represent current goals for type 2 diabetes management.

What the Phentermin/Topiramate Study Showed about Diabetes Goals
In the CONQUER study, there were 357 subjects with type 2 diabetes:  66% were female, the mean age was 52.6 years, mean weight was 100.9 kg, mean SBP was 125.9 mmHg, and the mean A1c was 6.8%.  Of the group, 70.8% were using metformin.

The subjects were randomized into 3 groups.  All groups involved lifestyle intervention.  There was a placebo group (PBO) (n = 144), a group assigned PHEN 7.5 mg/TPM ER 46 mg (7.5/46) (n = 63), and a group assigned PHEN 15 mg/TPM ER 92 mg (15/92) (n = 150).

At the end of the study, 11.8% of the PBO group achieved CG-A, but 27.0% of the 7.5/46 and 39.3% of the 15/92 groups achieved CG-A (p < 0.0001 for all).

In looking at CG-B, 4.2% of the PBO group achieved those goals.  In the 7.5/46 group, it was 14.3%, and in the 15/92 group, it was 31.3% (p < 0.0001 for all).

Of particular interest is that the need for diabetes and blood pressure medications decreased in the 7.5/46 and 15/92 groups—but increased in the PBO group.

There was a good level of tolerability for the PHEN/TPM ER medication, especially in the lower dose; only 9% of subjects in the 7.5/46 group discontinued the study due to adverse events.

What this Study Means for Type 2 Diabetes Management
Donna H. Ryan, MD, lead author of the study, said in a press conference at The Endocrine Society’s 94th Annual Meeting, “Medications to reinforce the behaviors that lead to weight loss can help patients better meet their diabetes goals.”

Extended-release phentermine/topiramate is currently under FDA review.