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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100125
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Drug: sitagliptin Drug: insulin dose increase Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 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