Inhaled insulin provides improved glycemic control in patients with type 2 diabetes mellitus inadequately controlled with oral agents: a randomized controlled trial
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Stuart R Weiss1, Shu-Lin Cheng, Ione A Kourides
1San Diego Endocrine and Medical Clinic, San Diego, CA 92009, USA.
Background:
The long-term benefits of good glycemic control are well established. The aim of this proof-of-concept study was to determine whether glycemic control can be improved in patients with type 2 diabetes mellitus with suboptimal glycemic control, despite therapeutic dosages of oral antihyperglycemic agents (OHAs), by the addition of preprandial inhaled insulin (INH).
Methods:
Sixty-eight patients with inadequately controlled type 2 diabetes mellitus (glycosylated hemoglobin, 8.1%-11.9%), despite therapy with a sulfonylurea and/or metformin, were randomized to receive INH in addition to their prestudy OHA therapy (INH + OHA group, n = 32) or to continue taking their prestudy OHA alone for 12 weeks (OHA group, n = 36). Premeal INH doses were delivered in 1 to 2 inhalations of 1-mg or 3-mg doses (equivalent to 3 IU and 9 IU, respectively, of subcutaneously injected regular insulin).
Results:
At week 12, there was a significantly greater reduction in glycosylated hemoglobin for the INH + OHA cohort (mean reduction, -2.3%) compared with the OHA-only cohort (mean reduction, -0.1%, P<.001). Eleven patients (34%) receiving INH + OHA achieved glycosylated hemoglobin values of less than 7%, compared with none taking OHAs only. Fasting plasma glucose improved significantly more in the INH + OHA group compared with the OHA-only group (-60.69 mg/dL (-3.37 mmol/L] greater reduction, P<.001), and the postprandial increase in glucose was significantly lower in those patients receiving INH + OHA (P =.02). There was 1 report of severe hypoglycemia in the INH + OHA group (home blood glucose, 54 mg/dL [3.0 mmol/L]) and a greater increase in body weight. Pulmonary function was unchanged in both groups.
Conclusion:
The addition of preprandial INH to existing OHAs improves glycemic control without the need for injections in patients with type 2 diabetes mellitus failing to achieve satisfactory control with OHAs alone.
Insights
Adding inhaled insulin (INH) to oral antihyperglycemic agents (OHAs) significantly improved glycemic control in type 2 diabetes patients. This injectable-free approach offers a new option for those not achieving targets with OHAs alone.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Pharmacology
Background:
- Good glycemic control is crucial for managing type 2 diabetes mellitus (T2DM).
- Many patients struggle to achieve target glycemic control with oral antihyperglycemic agents (OHAs) alone.
- Suboptimal glycemic control necessitates exploring alternative or add-on therapies.
Purpose of the Study:
- To evaluate the efficacy of adding preprandial inhaled insulin (INH) to existing OHA therapy.
- To determine if INH can improve glycemic control in T2DM patients with suboptimal control.
- To assess INH as an injectable-free treatment option.
Main Methods:
- A 12-week, randomized, proof-of-concept study.
- Sixty-eight T2DM patients with HbA1c 8.1%-11.9% were randomized.
- Groups received either INH + OHA or OHA alone.
Main Results:
- The INH + OHA group showed a significantly greater reduction in HbA1c (-2.3%) vs. OHA alone (-0.1%).
- 34% of patients on INH + OHA achieved HbA1c <7%, compared to none in the OHA-only group.
- Significant improvements in fasting and postprandial glucose were observed with INH + OHA.
Conclusions:
- Preprandial INH addition to OHAs effectively improves glycemic control in T2DM.
- This strategy offers an injectable-free alternative for patients with inadequately controlled T2DM.
- INH demonstrates potential for enhancing diabetes management without injections.
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