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Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment

This study has been completed.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital Identifier:
First received: April 5, 2010
Last updated: October 24, 2013
Last verified: October 2013

It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.

The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.

Condition Intervention Phase
Diabetes Drug: sitagliptin Drug: insulin dose increase Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy

Resource links provided by NLM:

Further study details as provided by Soo Lim, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The change of HbA1C [ Time Frame: 24weeks ]

Secondary Outcome Measures:
  • the number of patients in HbA1C <7% without hypoglycemia [ Time Frame: 24 weeks ]
  • hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL) [ Time Frame: 24 weeks ]
  • the change of C-peptide [ Time Frame: 24 weeks ]
  • the change of body weight and waist circumference [ Time Frame: 24 weeks ]
  • the change of insulin dose [ Time Frame: 24 weeks ]

Enrollment: 140
Study Start Date: April 2010
Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sitagliptin Drug: sitagliptin
sitagliptin 100mg once daily, orally, for 24 weeks.
Other Name: Januvia
Active Comparator: insulin dose increase Drug: insulin dose increase
insulin dose increase
Other Name: Long acting insulin (Lantus)


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
  • HbA1c ≥ 7%
  • Age ≥ 18
  • Insulin treatment with or without oral antidiabetic medication

Exclusion Criteria:

  • Contraindication to sitagliptin
  • Pregnant or breast feeding women
  • Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
  • Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
  • Renal failure (Cr > 2.0)
  • Cancer within 5 years
  • Not appropriate for oral antidiabetic agent
  • Medication which affect glycemic control
  • Disease which affect efficacy and safety of drugs
  • Other clinical trial within 30 days
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Please refer to this study by its identifier: NCT01100125

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Soo Lim, Assisstant Professor, Seoul National University Bundang Hospital Identifier: NCT01100125     History of Changes
Other Study ID Numbers: SNUBH_ENDO2
Study First Received: April 5, 2010
Last Updated: October 24, 2013

Keywords provided by Soo Lim, Seoul National University Bundang Hospital:

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Sitagliptin Phosphate
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017