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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01100125
First received: April 5, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The change of HbA1C [ Time Frame: 24weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of patients in HbA1C <7% without hypoglycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • the change of C-peptide [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • the change of body weight and waist circumference [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • the change of insulin dose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100125

Locations
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

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soo Lim, Assisstant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01100125     History of Changes
Other Study ID Numbers: SNUBH_ENDO2
Study First Received: April 5, 2010
Last Updated: October 24, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Diabetes
Sitagliptin
insulin
C-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014