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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

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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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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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