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A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia

This study has been completed.
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz Identifier:
First received: July 19, 2011
Last updated: February 4, 2013
Last verified: April 2012
The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Aspart, Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Single-centre, Controlled Trial to Investigate the Efficacy and Usability of Published Best Practice to Control Glycaemia in Hospitalised Patients With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by Pieber Thomas, MD, Medical University of Graz:

Primary Outcome Measures:
  • Mean blood glucose [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ]
    Mean blood glucose over 24 hours

Secondary Outcome Measures:
  • Number of glucose measurements in hyperglycaemic ranges [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ]

Enrollment: 74
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin titration protocol
Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes.
Drug: Insulin Aspart, Insulin Glargine
The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
No Intervention: Standard care
Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Blood glucose in the range between 140 - 400 mg/dl
  • Expected stay ≥ 48 hours

Exclusion Criteria:

  • Hyperglycemia without known history of type 2 diabetes mellitus
  • Impaired renal function (serum creatinine ≥3.0mg/dL)
  • Clinically relevant hepatic disease
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Please refer to this study by its identifier: NCT01407289

Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Thomas Pieber, MD Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pieber Thomas, MD, MD, Prof. of Medicine, Medical University of Graz Identifier: NCT01407289     History of Changes
Other Study ID Numbers: ClinDiab-02
Study First Received: July 19, 2011
Last Updated: February 4, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017