AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4TEDNCT02027753

Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy

A Phase 4 study testing INSULIN GLARGINE, Metformin and DPP-4 inhibitor in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea Secondary Objectives: 1. To assess the efficacy by adding insulin glargine 2. To assess insulin dose 3. Safety Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
INSULIN GLARGINE, Metformin and DPP-4 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteSouth Korea
Study dates
Dec 2013to Apr 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 Diabetes mellitus ≥ 20 aged
  • Patients who are treated with DPP- 4 for at least 3 months before informed consent with metformin plus or minus sulphonylurea inadequately controlled with HbA1c ≥ 7.5%
  • Be able and voluntarily agree to participate in this study by signing a written informed consent

Who cannot join

  • Diabetes patients other than Type 2 (eg. Type 1 Diabetes mellitus, pancreatic disease, secondary diabetes)
  • HbA1c > 11% at screening
  • History of continuous basal insulin treatment within 1 year before screening
  • History of diabetic acidosis (including keto-acidosis) within 1 year before screening
  • History of myocardial infarct, stroke or heart failure related admission within 3 months before screening
  • History of drug or alcoholic abuse within 6 months before screening
Show all 24Show fewer
  • Weight change ≥ 5 kg within 3 months before screening
  • History of hypoglycemic unawareness
  • Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg regardless of taking anti-hypertensive, or uncontrolled hypertension
  • Active malignant cancer, major systemic disease, clinically significant diabetic retinopathy, macular edema necessitating laser treatment, abnormal clinical finding from physical examination, lab analysis, electrocardiogram or vital sign, which can be regarded as to prevent safe completion of clinical study or to make efficacy assessment difficult by investigator or co-investigator at screening
  • Pregnant or lactating women
  • Women of child bearing potential (Pre-menopause or not surgically infertile within 3 months before screening) who match two conditions below:
  • Negative serum pregnancy test at screening
  • Using medically proven effective contraceptive method
  • Hypersensitivity to investigational drugs
  • Lab finding at screening:
  • Abnormal liver function: Alanine transaminase or Alkaline phosphatase > 3 times of upper limit of normal range
  • Renal insufficiency: Men with serum Cr ≥ 1.5 mg/dL (≥ 133µmol/L), women with serum Cr ≥ 1.4 mg/dL (≥ 124 µmol/L)
  • Use of anti-obese drug within 3 months before screening
  • Has been using drugs that can influence glucose metabolism (systemic corticosteroid, thyroid hormone) within 3 months before screening or has possibility of using these drug during the investigational period
  • Has participated in clinical studies of any investigational drugs within 3 months before screening
  • Considered not physically or psychologically appropriate to participate in clinical study by investigator
  • Not willing to comply with scheduled visit, self-inject insulin, or self-monitor blood glucose level
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Sanofi-Aventis Administrative Office

    Seoul

Other trials in South Korea

About this study

Official title: Efficacy and Safety of TrEating Type 2 Diabetic Patients With Inadequate Response to Metformin and DPP-4 Inhibitors by Adding Basal Insulin Therapy (Insulin Glargine)

Primary Objective:

To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea

Secondary Objectives:

  1. To assess the efficacy by adding insulin glargine
  2. To assess insulin dose
  3. Safety
Read the detailed description

28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)

Being tested
INSULIN GLARGINE, Metformin, DPP-4 inhibitor, Sulphonylurea
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINEDrug

    Pharmaceutical form: solution Route of administration: subcutaneous

  • MetforminDrug

    Pharmaceutical form: tablet Route of administration: oral

  • DPP-4 inhibitorDrug

    Pharmaceutical form: tablet Route of administration: oral

  • SulphonylureaDrug

    Pharmaceutical form: tablet Route of administration: oral

Study groups in NCT02027753
Study groupRoleWhat they receive
Insulin glargine and Oral anti diabetic treatment(s)Experimental1. Insulin glargine: Lantus * Add basal insulin: starting with 0.2 U/kg/day or 10 U/day * Adjust insulin glargine dose according to Fasting blood glucose 2. Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
Receives: Drug: INSULIN GLARGINE; Drug: Metformin; Drug: DPP-4 inhibitor; Drug: Sulphonylurea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy

    Measured: week 24 (6 months)

Secondary outcomes (10)

  1. Percentage of patients with HbA1c ≤7%

    Measured: week 12 (3 months)

  2. Change from baseline in HbA1c

    Measured: week 12 (3 months), week 24 (6 months)

  3. Percentage of patients with HbA1c ≤6.5%

    Measured: week 12 (3 months), week 24 (6 months)

  4. Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose

    Measured: week 12 (3 months), week 24 (6 months)

  5. Total daily insulin dose

    Measured: week 24 (6 months)

  6. Fasting blood glucose (FBG) values

    Measured: During 3 consecutive days before baseline, week 12, Week 24

  7. 7-point Self Monitoring of Blood Glucose

    Measured: During 2 days within 7 days before baseline, week 12, week 24

  8. Weight change from baseline

    Measured: week 24 (6 months)

  9. Number of Patients with Hypoglycemic Events

    Measured: up to 6 months

  10. Number of Patients with Adverse Events

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02027753
Sponsor's protocol ID
LANTUL06638
Other IDs
U1111-1149-1632
Acronym
TED
Status last verified
Aug 2015
First submitted
3 Jan 2014
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE, Metformin and DPP-4 inhibitor in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy (time frame: week 24 (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02027753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in