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Clinical trials

The SUSTAIN program: semaglutide's glucose evidence

The diabetes trials that led to semaglutide's first approval, as Ozempic.

Reviewed 2026-06-04 Physician-reviewed How we research

Quick Answer

The SUSTAIN program established injectable semaglutide's efficacy in type 2 diabetes, supporting its approval as Ozempic. Across the trials, semaglutide produced large A1c reductions (commonly ~1.5–1.8 percentage points) plus weight loss, and SUSTAIN-6 showed a reduction in major cardiovascular events in high-risk patients. Compounded semaglutide is not FDA-approved.

Key Facts

  • Phase-3 diabetes trials supporting Ozempic's approval
  • A1c reductions commonly around 1.5–1.8 percentage points
  • Weight loss alongside glucose lowering
  • SUSTAIN-6: reduced major cardiovascular events in high-risk T2D
  • Compounded semaglutide is not FDA-approved

What SUSTAIN was

SUSTAIN was a series of phase-3 trials testing injectable semaglutide in type 2 diabetes against placebo and active comparators. Together they formed the evidence base for semaglutide's first approval, as Ozempic, for glycemic control.

Glucose and weight results

Across the program, semaglutide produced substantial A1c reductions — commonly around 1.5–1.8 percentage points at higher doses — with high proportions reaching targets such as below 7%. Unlike many older diabetes drugs, it also produced meaningful weight loss, which led to the dedicated obesity program (STEP).

Cardiovascular signal: SUSTAIN-6

SUSTAIN-6 (NEJM, 2016) was a cardiovascular outcomes trial in high-risk type 2 diabetes. Semaglutide reduced the rate of major adverse cardiovascular events versus placebo — an early signal of cardiovascular benefit that was later extended to people without diabetes in SELECT.

Caveats

These are diabetes trials; the medication's role and dosing in any individual is a clinical decision. The branded product was studied. Compounded semaglutide is not FDA-approved.

Frequently asked questions

How much does semaglutide lower A1c?

In SUSTAIN trials, higher doses commonly lowered A1c by about 1.5–1.8 percentage points, depending on the trial and background therapy.

Does semaglutide help the heart in diabetes?

SUSTAIN-6 showed a reduction in major cardiovascular events in high-risk type 2 diabetes; cardiovascular care is individualized.

References

  1. Marso SP, et al. Semaglutide and cardiovascular outcomes in type 2 diabetes (SUSTAIN-6). N Engl J Med. 2016;375:1834-1844.
  2. Wilding JPH, et al. Once-weekly semaglutide in adults with overweight or obesity (STEP 1). N Engl J Med. 2021;384:989-1002.
  3. U.S. Food and Drug Administration. Wegovy, Ozempic and Rybelsus (semaglutide) prescribing information. Novo Nordisk.

Citations are for educational reference; this article summarizes published research in plain language and is not medical advice.

Bottom Line

The SUSTAIN program established semaglutide's strong glucose lowering and weight loss in type 2 diabetes, and SUSTAIN-6 showed cardiovascular benefit in high-risk patients.

Related from the Journal

SELECT trial

CV outcomes without diabetes.

PIONEER program

Oral semaglutide evidence.

STEP 2

Weight in diabetes.

Compounded semaglutide is not FDA-approved as a finished drug product. Compounded medications may be prescribed only when clinically appropriate and must be evaluated by a licensed prescriber. Branded medications such as Wegovy and Ozempic are FDA-approved products; compounded semaglutide is different and should not be described as FDA-approved, “generic Wegovy,” or “generic Ozempic.”
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