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Veterans Affairs Cooperative Study on Glycemic Control and Complications in Type II Diabetes (VA CSDM): Results of the feasibility trial

Abraira, Carlos, Colwell, John A, Nuttall, Frank Q, Sawin, Clark T, Nagel, Nancy Johnson, Comstock, John P, Emanuele, Nicholas V, Levin, Seymour R +3 more·1995·Diabetes Care
DOI 10.2337/diacare.18.8.1113
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Abstract

OBJECTIVE: It is not clear whether intensive pharmacological therapy can be effectively sustained in non-insulin-dependent diabetes mellitus (NIDDM). The relative risks and benefits of intensive insulin therapy in NIDDM are not well defined. Accordingly, we designed a feasibility study that compared standard therapy and intensive therapy in a group of NIDDM men who required insulin due to sustained hyperglycemia. RESEARCH DESIGN AND METHODS: A prospective trial was conducted in five medical centers in 153 men of 60 ± 6 years of age who had a known diagnosis of diabetes for 7.8 ± 4 years. They were randomly assigned to a standard insulin treatment group (one morning injection per day) or to an intensive therapy group designed to attain near-normal glycemia and a clinically significant separation of glycohemoglobin from the standard arm. A four-step plan was used in the intensive therapy group along with daily self-monitoring of glucose: 1) an evening insulin injection, 2) the same injection adding daytime glipizide, 3) two injections of insulin alone, and 4) multiple daily injections. Patient accrual and adherence, glycohemoglobin (HbA1c), side effects, and measurements of endpoints for a prospective long-term trial were assessed. RESULTS: Accrual goals were met, mean follow-up time was 27 months (range 18–35 months), and patients kept 98.6% of scheduled visits. After 6 months, the mean HbA1c in the intensive therapy group was at or below 7.3% and remained 2% lower than the standard group for the duration of the trial. Most of the decrease in the mean HbA1c in the intensive group was obtained by a single injection of evening intermediate insulin, alone or with daytime glipizide. By the end of the trial, 64% of the patients had advanced to two or more injections of insulin a day, aiming for normal HbA1c. However, only a small additional fall in HbA1c was attained. Severe hypoglycemia was rare (two events per 100 patients per year) and not significantly different between the groups, nor were changes in weight, blood pressure, or plasma lipids. There were 61 new cardiovascular events in 40 patients and 10 deaths (6 due to cardiovascular causes). CONCLUSIONS: Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal glycemic control for > 2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia. Cardiovascular event rates are high at this stage of NIDDM. A long-term prospective trial is needed to assess the risk-benefit ratio of intensified treatment of hyperglycemia in NIDDM patients requiring insulin.

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  • In clinical trials aimed at normoglycemia and achieving a mean A1C of approximately 7%, severe hypoglycemic episodes occurred at a rate of between one and three per 100 patient-years.

    “In clinical trials aimed at normoglycemia and achieving a mean A1C of ∼7%, severe hypoglycemic episodes (defined as requiring help from another person to treat) occurred at a rate of between one and three per 100 patient-years (8,75–77)”

    From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [75]

  • In the VA CSDM, the overall incidence of severe hypoglycemia was 0.02 episodes per patient per year, and no significant difference was observed between the standard and stepped treatment groups.

    “The overall incidence of severe hypoglycemia was 0.02 episodes per patient per year, and no significant difference was observed between the standard and stepped treatment groups.”

    From Hypoglycemia in Type 2 Diabetes (2005) · cites this paper as [74]

  • The frequency of mild hypoglycemia was significantly higher in the intensively treated group (stepped vs. standard: 16.5 vs. 1.5 episodes per patient per year), but in the standard treatment group blood glucose was monitored less frequently so mild hypoglycemia may have been underreported.

    “The frequency of mild hypoglycemia was significantly higher in the intensively treated group (stepped vs. standard: 16.5 vs. 1.5 episodes per patient per year), but in the standard treatment group blood glucose was monitored less frequently so mild hypoglycemia may have been underreported (74).”

    From Hypoglycemia in Type 2 Diabetes (2005) · cites this paper as [74]

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Authors
Abraira, C., Colwell, J. A., Nuttall, F. Q., Sawin, C. T., Nagel, N. J., Comstock, J. P., Emanuele, N. V., Levin, S. R., Henderson, W., Lee, H. S., & VA CSDM Group
Affiliations
  • United States Department of Veterans Affairs (US)
  • Department of Veterans Affairs Cooperative Studies Program Hines, Illinois
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
1995-08-01
Volume
18
Issue
8
Pages
1113-1123
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/diacare.18.8.1113
OpenAlex
W2091034695
Cited by
355
References
0
Citations by year
2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 2 · 2020: 5 · 2019: 1 · 2018: 6 · 2017: 9 · 2016: 7 · 2015: 11 · 2014: 7 · 2013: 16 · 2012: 13
FWCI
11.33
Type
journal article
Language
en
Open access
closed
Locations
  • Diabetes Care (publishedVersion)
  • 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 › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
type 2 diabetes, intensive insulin therapy, glycemic control, glycohemoglobin, multiple daily insulin injections, glipizide, self-monitoring of blood glucose, hypoglycemia, diabetes complications, cardiovascular events, trial feasibility, veterans, diabetic men, medication adherence, mortality, diabetes morbidity
MeSH terms
Aged, Albuminuria, Animals, Blood Glucose, Blood Pressure, Cholesterol, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Retinopathy, Feasibility Studies, Glipizide, Glycated Hemoglobin, Hospitals, Animal, Humans, Hypoglycemic Agents, Insulin, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Quality Control, Smoking, Time Factors, Triglycerides, United States, Blood Glucose Self-Monitoring, Biomarkers, Body Mass Index, Patient Selection

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