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Type 2 Diabetes MellitusNCT00147836

Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients

A study testing Human Insulin (Novolin-R, Novo Nordisk), H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland and Pre-meal in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen 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 purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients. Read more about this study

Who is it for?
Ages 25 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Human Insulin (Novolin-R, Novo Nordisk), H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland and Pre-meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
1 siteChina
Study dates
Sep 2004to Oct 2007
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 25 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • informed consents be given before treatment
  • the newly-diagnosed type 2 diabetic patients
  • fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
  • age ranging from 25～70 years old
  • body mass index (BMI) ranging from20～35kg/m2
  • never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents

Who cannot join

  • having any severe acute or chronic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the normal level)
  • any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
  • serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
  • chronic or acute pancreatic disease
Show all 12Show fewer
  • severe systematic diseases or malignant tumor
  • allergic to the drugs using in the trial
  • any factors interfering the result
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance

Trial locations and contacts

1 site in 1 country.

China1 site

  • the first Affiliated Hospital of Sun Yat-Sen university

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients

The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

Read the detailed description

ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. With continuous presence of insulin resistance, progressive loss of ß-cell function is the crucial defect. Hyperglycemia has deleterious effect on β-cell function, which is partially reversible by adequate glycemic control. In newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks continuous subcutaneous insulin infusion (CSII) can induce adequate glycemic control with improvement of β-cell function. Nearly half of the patients can maintain euglycemia longer than 12 months by transient CSII. The improvement of β-cell function, especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients. But it is unclear whether any other interventions (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic control in a short period of time can have the same effect. As a multicenter, open-label, randomized, parallel-group study will be needed to further prove and clarify the findings.

Being tested
Human Insulin (Novolin-R, Novo Nordisk), H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland, Pre-meal, Novolin-R, Human Insulin NPH (Novolin-N, Novo Nordisk)
Keywords
type 2 diabetes mellitus, therapy, sulfonylureas, metformin, insulin
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

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

  • Human Insulin (Novolin-R, Novo Nordisk)Drug

  • H-Tron Plus V100; Disetronic Medical System, Burgdorf, SwitzerlandDevice

  • Pre-mealOther

  • Novolin-RDrug

  • Human Insulin NPH (Novolin-N, Novo Nordisk)Drug

  • Gliclazide (Diamicron, Servier)Drug

  • Diamicron and GlucophageDrug

Study groups in NCT00147836
Study groupRoleWhat they receive
CSIIActive comparatorPatients in continuous subcutaneous insulin infusion group received Human Insulin (Novolin-R, Novo Nordisk) with an insulin pump (H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland);
Receives: Drug: Human Insulin (Novolin-R, Novo Nordisk); Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
MDIActive comparatorPatients in MDI group were treated with pre-meal Novolin-R, and Human Insulin NPH (Novolin-N, Novo Nordisk) at bedtime. Initial insulin doses were 0.4-0.5 IU/kg and total daily doses were divided into 50% of basal and 50% of bolus injection in CSII group and 30%-20%-20%-30% in multiple daily insulin injection group
Receives: Other: Pre-meal; Drug: Novolin-R; Drug: Human Insulin NPH (Novolin-N, Novo Nordisk)
OHAActive comparatorIn oral hpoglycemic agents group, the patients with 20 kg/m2<BMI≤25kg/m2 were initiated with Gliclazide (Diamicron, Servier) 80mg Bid (maximum to 160mg Bid), the patients with 25kg/m2<BMI≤35kg/m2 were initiated with Metformin (Glucophage, BMS) 0.5 Bid (maximum to 2.0g/d), the combination of Diamicron and Glucophage was used in patients who could not achieve glycaemic control goal with one OHA or with FPG≥11.1mmol/l at randomization
Receives: Drug: Gliclazide (Diamicron, Servier); Drug: Diamicron and Glucophage

What is being measured

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

  1. glycemic control, the improvement of β-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients

    Measured: Oct. 2007

Secondary outcomes (1)

  1. the effects of different interventions (oral anti-hyperglycemic agents, multiple daily injections and continuous subcutaneous insulin infusion) on glycemic control, β-cell function and the remission rate in newly-diagnosed type 2 diabetic patients

    Measured: Oct. 2007

Timeline

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

  1. First posted7 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionOct 2007
  4. Study completionOct 2007

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
436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147836
Sponsor's protocol ID
NECT-2004-WJP
Other IDs
GSTB-05100981-LYB
Status last verified
Oct 2007
First submitted
4 Sep 2005
Last updated
1 Apr 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.

    PubMed 15504992

  • Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.

    PubMed 18502299

Questions about this trial

What is this clinical trial studying?

A study testing Human Insulin (Novolin-R, Novo Nordisk), H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland and Pre-meal in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen 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 6 inclusion and 12 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 1 Apr 2008. 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?

glycemic control, the improvement of β-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients (time frame: Oct. 2007). 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 NCT00147836, which also lists 2 linked publications.

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 1 Apr 2008.

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