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NCT Number: NCT01100125

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sitagliptin

Drug

sitagliptin 100mg once daily, orally, for 24 weeks.

Other names: Januvia

insulin dose increase

Drug

insulin dose increase

Other names: Long acting insulin (Lantus)

Primary outcomes

  1. The change of HbA1C

    Time frame: 24weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2010
Registry last updated
Oct 25, 2013

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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