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OpenTrials
Completed

NCT Number: NCT01480843

Simplified Insulin Protocol Using Lantus in Elderly

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 70 years or older
  • Diagnosis of diabetes mellitus Type II
  • At least 2 (short-acting or mixed) insulin injections per day
  • At least 1 episode of hypoglycemia (glucose value <70) on screening CGM

Exclusion criteria

  • Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
  • Active liver disease (history of cirrhosis or LFT > 3 times normal)
  • On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)
  • Malignancy that limits life span to less than 18 months
  • Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

Treatment and study plan

Glargine

Drug

Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Other names: Lantus

Primary outcomes

  1. Change in Duration of Hypoglycemia Episodes

    Time frame: baseline, 5 months, 8 months

    duration of hypoglycemia measured by continuous glucose monitoring

  2. Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months

    Time frame: baseline, 5 months, 8 months

    frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Sanofi

Registry information

Official study title

Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Acronym: SIMPLE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 29, 2011
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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