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DiabetesNCT00978263

Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

A study testing metformin-based Oral Antidiabetic Drugs and Glargine in people with Diabetes, run by Chongqing Medical University at 1 site in China.

Completed

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

Official record
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Trial summary

The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glucose toxicity with a short period of intensive insulin therapy. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes
What is being tested?
metformin-based Oral Antidiabetic Drugs and Glargine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
Feb 2009to Jun 2012
Phase
Interventional
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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed type 2 diabetic patients.
  • Drug naïve, with severe hyperglycemia (fasting plasma glucose>11.1mmol/L or random plasma glucose >16.7mmol/L)
  • Those who age between 30 and 70 years old and can inject insulin by themselves.

Who cannot join

  • Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;
  • Malignancy, pregnancy or lactating;
  • History of ketoacidosis;
  • Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine >2 mg/dl;
  • Poor blood pressure control (SBP>180mmHg or DBP >110mmHg);
  • Definite coronary artery disease, heart failure, left ventricular hypertrophy;
Show all 11Show fewer
  • Severe anemia; acute or severe chronic diabetes complications;
  • BMI<18 kg/m2 or ≥41kg/m2;
  • History of alcohol abuse or drug abuse;
  • Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;
  • Chronic diseases need long-term glucocorticoid treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

Official title: An Efficacy and Safety Comparison of Basal Insulin and OADs in Newly Diagnosed Type 2 Diabetes After Short-term Intensive Insulin Therapy

The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.

Read the detailed description

Detailed Description:

OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify whether basal insulin glargine or metformin-based OADs for further management would have a long-term benefit in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients (fasting blood glucose >200 mg/dL or random blood glucose >300 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. HbA1c were measured before intensive insulin injection. After discharge, patients will be randomized to receive basal insulin injection or metformin-based OADs for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. HbA1c were measured 6 months later.After the six-month intervention, these patients were continually followed up for another six months. Subjects received an oral glucose tolerance test (OGTT) after the intensive insulin therapy and at the end of the 6th and 12th month.

EXPECTED RESULTS-We will expect that basal insulin glargine,compared with metformin-based OAD treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

Conditions
Diabetes
Being tested
metformin-based Oral Antidiabetic Drugs, Glargine
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • metformin-based Oral Antidiabetic DrugsDrug

    Also called Metformin and so on

  • GlargineDrug

    Also called Lantus

Study groups in NCT00978263
Study groupRoleWhat they receive
GlargineExperimentalInitial basal Insulin therapy was according to the dose administrated at bedtime in the last day hospitalization. basal Insulin doses were titrated every 3 days to achieve target FPG values between 80 and 130 mg/dl.
Receives: Drug: Glargine
metformin-based Oral Antidiabetic DrugsExperimentalSubject in metformin-based OAD group was visited every two weeks in the first month and the every four weeks for another five months. The subjects will start with Metformin 425mg bid, The dosage was titrated (up to 850mg bid) based on the fasting blood glucose every two weeks. If the patients fail to achieve the target, gliclazide-MR (Diamicron, Servier), or glimepiride (Amaryl, Sanofi-Aventis) would be added.
Receives: Drug: metformin-based Oral Antidiabetic Drugs

What is being measured

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

  1. Glycosylated Hemoglobin (HbA1c) at month 6

    Measured: month 6

  2. Change From Baseline in Glycosylated Hemoglobin at month 6

    Measured: Baseline and month 6

Secondary outcomes (39)

  1. Glycosylated Hemoglobin at month 12

    Measured: month 12

  2. Change From Baseline in Glycosylated Hemoglobin at month 12

    Measured: Baseline and month 12

  3. Number of Participants With Glycosylated Hemoglobin ≤ 7%

    Measured: month 6

  4. Number of Participants With Glycosylated Hemoglobin ≤ 7%

    Measured: month 12

  5. Number of Participants With Glycosylated Hemoglobin ≤ 6.5%

    Measured: month 6

  6. Number of Participants With Glycosylated Hemoglobin ≤ 6.5%

    Measured: month 12

  7. Fasting Plasma Glucose at week 2

    Measured: week 2

  8. Fasting Plasma Glucose at week 4

    Measured: week 4

  9. Fasting Plasma Glucose at week 8

    Measured: week 8

  10. Fasting Plasma Glucose at week 12

    Measured: week 12

  11. Fasting Plasma Glucose at week 16

    Measured: week 16

  12. Fasting Plasma Glucose at week 20

    Measured: week 20

  13. Fasting Plasma Glucose at week 24

    Measured: week 24

  14. Fasting Plasma Glucose at week 32

    Measured: week 32

  15. Fasting Plasma Glucose at week 40

    Measured: week 40

  16. Fasting Plasma Glucose at week 48

    Measured: week 48

  17. Homeostasis model assessment (HOMA)-β at month 6

    Measured: month 6

  18. Insulinogenic index at month 6

    Measured: month 6

  19. HOMA-IR at month 6

    Measured: month 6

  20. Matsuda index at month 6

    Measured: month 6

  21. Basal disposition index at month 6

    Measured: month 6

  22. Early-phase disposition index at month 6

    Measured: month 6

  23. Homeostasis model assessment (HOMA)-β at month 12

    Measured: month 12

  24. Insulinogenic index at month 12

    Measured: month 12

  25. HOMA-IR at month 12

    Measured: month 12

  26. Matsuda index at month 12

    Measured: month 12

  27. Basal disposition index at month 12

    Measured: month 12

  28. Early-phase disposition index at month 12

    Measured: month 12

  29. Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score

    Measured: month 6

  30. DTSQs score at month 12

    Measured: month 12

  31. Audit of Diabetes Dependent Quality of Life (ADDQoL) score

    Measured: month 6

  32. ADDQoL score at month 12

    Measured: month 12

  33. Cost at month 6

    Measured: month 6

  34. Number of Participants with Hypoglycemia

    Measured: up to 6 month

  35. Number of hypoglycemia episodes

    Measured: up to 6 month

  36. Number of Participants with severe Hypoglycemia

    Measured: up to 6 month

  37. Number of severe hypoglycemia episodes

    Measured: up to 6 month

  38. Change From Baseline in Body Weight (month 6)

    Measured: Baseline and month 6

  39. Change From Baseline in Body Weight (month 12)

    Measured: Baseline and month 12

Timeline

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

  1. First posted16 Sep 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2011
  4. Study completionJun 2012

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00978263
Sponsor's protocol ID
ChongqingMU
Status last verified
Feb 2013
First submitted
14 Sep 2009
Last updated
5 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing metformin-based Oral Antidiabetic Drugs and Glargine in people with Diabetes, run by Chongqing Medical University at 1 site in China.

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 11 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 5 Feb 2013. 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 China. 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.

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?

Glycosylated Hemoglobin (HbA1c) at month 6 (time frame: month 6). The study lists 2 primary outcomes in all. 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 NCT00978263.

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 5 Feb 2013.

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