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Completed

NCT Number: NCT02338921

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soo Lim

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes.

Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome proliferator-activated receptors (PPARs) agonists.

But, there have been few studies about the glucose lowering effect of these drugs in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.

Hence, the researchers plan to investigate the efficacy and safety of these drugs in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 ≤ Age < 80 years
  • HbA1c ≥ 7 %
  • combination therapy with glimepiride and metformin over 2 months.
  • dosage of glimepiride : 1-8mg/day
  • dosage of metformin : 500-2550mg/day

Exclusion criteria

  • Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
  • Contraindication to sitagliptin or dapagliflozin or lobeglitazone
  • Pregnant or breast feeding women
  • Medication which affect glycemic control (ex. steroid)
  • Disease which affect efficacy and safety of drugs
  • Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)
  • Not appropriate for oral antidiabetic agent

Treatment and study plan

Sitagliptin

Drug

100mg qd per oral during 24months

compared with other treatment groups

Other names: Januvia

Dapagliflozin

Drug

10mg qd per oral during 24months

compared with other treatment groups

Other names: Forxiga

Lobeglitazone

Drug

0.5mg qd per oral during 24months

compared with other treatment groups

Other names: Duvie

Glimepirde

Drug

Other names: Amaryl

metformin

Drug

Primary outcomes

  1. Glycemic target goal achievement rate

    Time frame: 24 months

    HbA1c< 7.0% without hypoglycemia

Secondary outcomes

  1. Beta-cell function

    Time frame: 6 and 24 months

    Beta-cell function

  2. insulin resistance

    Time frame: 6 and 24 months

    insulin resistance

  3. Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)

    Time frame: 3,6,9,12,16,20 and 24months

    Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)

  4. Lipid profile

    Time frame: 3,6,9,12,16,20 and 24months

    Lipid profile

  5. Body fat

    Time frame: 6,12 and 24 months

    Body fat

  6. urine microalbumin to creatinine ratio

    Time frame: 6,12 and 24 months

    urine microalbumin to creatinine ratio

  7. Change of HbA1c

    Time frame: 3,6,9,12,16,20 and 24months

    Change of HbA1c

  8. Glycemic target goal achievement rate

    Time frame: 12 months

    HbA1c< 7.0% without hypoglycemia

Other outcomes

  1. hypoglycemia

    Time frame: 3,6,9,12,16,20 and 24months

    hypoglycemia

  2. body weight change

    Time frame: 6 and 24 months

    body weight change

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin.

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2015
Registry last updated
Jan 4, 2022

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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