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The Efficacy and Safety of Saxagliptin When Added to Metformin Therapy in Patients With Inadequately Controlled Type 2 Diabetes With Metformin Alone

Open access
DeFronzo, Ralph A., Hissa, Miguel N., Garber, Alan J., Luiz Gross, Jorge, Yuyan Duan, Raina, Ravichandran, Shoba, Chen, Roland S., for the Saxagliptin 014 Study Group·2009·Diabetes Care
DOI 10.2337/dc08-1984PMC PMC2732156
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Abstract

OBJECTIVE: This 24-week trial assessed the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes with inadequate glycemic control with metformin alone. RESEARCH DESIGN AND METHODS: This was a randomized, double-blind, placebo-controlled study of saxagliptin (2.5, 5, or 10 mg once daily) or placebo plus a stable dose of metformin (1,500–2,500 mg) in 743 patients (A1C ≥7.0 and ≤10.0%). Efficacy analyses were performed using an ANCOVA model using last observation carried forward methodology on primary (A1C) and secondary (fasting plasma glucose [FPG] and postprandial glucose [PPG] area under the curve [AUC]) end points. RESULTS: Saxagliptin (2.5, 5, and 10 mg) plus metformin demonstrated statistically significant adjusted mean decreases from baseline to week 24 versus placebo in A1C (−0.59, −0.69, and −0.58 vs. +0.13%; all P < 0.0001), FPG (−14.31, −22.03, and −20.50 vs. +1.24 mg/dl; all P < 0.0001), and PPG AUC (−8,891, −9,586, and −8,137 vs. −3,291 mg · min/dl; all P < 0.0001). More than twice as many patients achieved A1C <7.0% with 2.5, 5, and 10 mg saxagliptin versus placebo (37, 44, and 44 vs. 17%; all P < 0.0001). β-Cell function and postprandial C-peptide, insulin, and glucagon AUCs improved in all saxagliptin treatment groups at week 24. Incidence of hypoglycemic adverse events and weight reductions were similar to those with placebo. CONCLUSIONS: Saxagliptin once daily added to metformin therapy was generally well tolerated and led to statistically significant improvements in glycemic indexes versus placebo added to metformin in patients with type 2 diabetes inadequately controlled with metformin alone.

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Figure 1 Effect of saxagliptin added to metformin versus placebo added to metformin. A: A1C mean change from baseline values (last observation carried forward [LOCF]) during the 24-week treatment period. B: Mean fasting plasma glucose values (LOCF) during the 24-week treatment period. C: Postprandial glucose 3-h AUC during the OGTT (LOCF): baseline versus week 24.
Figure 1 Effect of saxagliptin added to metformin versus placebo added to metformin. A: A1C mean change from baseline values (last observation carried forward [LOCF]) during the 24-week treatment period. B: Mean fasting plasma glucose values (LOCF) during the 24-week treatment period. C: Postprandial glucose 3-h AUC during the OGTT (LOCF): baseline versus week 24.CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 2

  1. Bosi, 2007, Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin, Diabetes Care, 30, 890, 10.2337/dc06-1732 · DOI
  2. 2006, Januvia (sitagliptin) tablets [package insert]

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Metadata

Authors
DeFronzo, R. A., Hissa, M. N., Garber, A. J., Luiz Gross, J., Yuyan Duan, R., Ravichandran, S., Chen, R. S., & for the Saxagliptin 014 Study Group
Affiliations
  • The University of Texas at San Antonio Health Science Center (US)
  • Hospital Universitário Walter Cantídio (BR)
  • Baylor College of Medicine (US)
  • Centro De Pesquisa Em Diabetes, Porto Alegre, Rio Grande Do Sul, Brazil;
  • Bristol-Myers Squibb Company, Princeton, New Jersey.
  • Bristol-Myers Squibb (United States) (US)
Corresponding author
DeFronzo, Ralph A.
ORCID
DeFronzo, Ralph A.
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2009-05-28
Volume
32
Issue
9
Pages
1649-1655
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc08-1984
PMC
PMC2732156
OpenAlex
W2103058881
Cited by
416
References
22
Citations by year
2026: 4 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 7 · 2021: 3 · 2020: 11 · 2019: 8 · 2018: 8 · 2017: 23 · 2016: 31 · 2015: 29 · 2014: 44 · 2013: 34 · 2012: 49
FWCI
49.05
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Care (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
Keywords
saxagliptin, metformin, type 2 diabetes, adjunctive therapy, inadequate glycemic control, glycemic control, HbA1c, fasting blood glucose, postprandial blood glucose, beta-cell function, C-peptide, hypoglycemia, drug safety, weight loss, DPP-4 inhibitors, DPP-4 inhibition, insulin secretion, glucagon
MeSH terms
Adamantane, Adolescent, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Dipeptides, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Placebos, Treatment Outcome, Young Adult

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