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Home » Trials » SLCTR/2014/024

A randomized controlled trial to compare insulin and metformin versus metformin and sulphonyluria on the short term outcomes after Coronary Artery bypass graft (CABG) in patients with type 2 diabetes

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SLCTR Registration Number

SLCTR/2014/024

Date of Registration

07 Oct 2014

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

A randomized controlled trial to compare insulin and metformin versus metformin and sulphonyluria on the short term outcomes after Coronary Artery bypass graft (CABG) in patients with type 2 diabetes

Public Title of Trial

Blood sugar control after bypass operation - insulin vs oral medication

Disease or Health Condition(s) Studied

heart disease, diabetes

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1161-0670

Any other number(s) assigned to the trial and issuing authority

EC/14/098 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)


Trial Details

What is the research question being addressed?

Does changing of anti diabetic drug regimen on discharge to metformin plus cardiac safe sulphonyluria result in short term outcomes which are similar to use of metformin plus insulin in patients with mild - moderate diabetes who have undergone CABG ?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Available

Intervention(s) planned

Consenting patients will be randomized into two arms using a random number table. Randomization will be done around post operative day three when the patient has achieved satisfactory glycaemic control with insulin during the intra-operative and post-operative period.

Arm one will receive insulin and metformin, and arm two will receive metformin and a sulphonyluria (gliclazide).

The Initial dose of metformin will be 500mg three times daily for both arms. Depending on the patient requirement and tolerability the dose will be titrated slowly to a maximum dose of 2g per day.

Arm one will receive pre mixed (Mixtard) insulin twice a day with or without lunch time soluble insulin depending on blood glucose control.

Arm two will receive gliclazide with a starting dose based on previous insulin requirement (total daily dose between 40mg – 160mg). The dose will be titrated depending on blood glucose control to a maximum of 320mg per day.

While hospitalized, the target pre meal capillary blood glucose (CBG) will be below 140 mg/dl and random blood glucose (RBG) will be below 180 mg/dl (American Diabetic Association cutoffs).

During the follow up period the target fasting blood glucose (FBG) will be below 100mg/dl and post prandial blood glucose (PPBG) will be below 140mg/dl.

All patients will be followed up at the diabetic clinic, NHSL. All patients will be educated on life style modification including diet control, regular exercise , need of cessation of smoking etc by medical officers and diabetic educating nursing officers during hospital stay and at each clinic visit

Inclusion criteria

  1. Patients with type 2 diabetes admitted to Cardio-thoracic units of the National Hospital of Sri Lanka for coronary artery bypass grafting (CABG)
  2. Daily insulin requirement of <1IU/kg/day to achieve satisfactory glycaemic control

Exclusion criteria

  1. Patients on insulin prior to admission due to oral hypoglycaemic (OHG) failure
  2. Daily insulin requirement following CABG >1IU/kg/day.
  3. Serum creatinine > 1.5 mg/dl
  4. Unstable cardiac failure
  5. Chronic liver disease
  6. Patients taking drugs affecting glycaemic control (eg. Steroids)
  7. Patients unable to return for follow-up
  8. Patients who are unable to understand or cooperate with protocol requirements

Primary outcome(s)

1.
  1. HbA1c
  2. FBG
  3. PPBG
 [
  1. HbA1c will be done at 3 months after discharge
  2. FBG and PPBG will be done at one week, one month, two months and three months after discharge
]

Secondary outcome(s)

1.

  1. Surgical wound infection occurring within 30 days of surgery (at least one of the following: purulent discharge from surgical site or drain, organisms isolated from aseptically obtained wound culture, signs and symptoms of infection such as pain or tenderness, localized swelling, or redness/heat).

  2. Acute coronary syndrome: Angina associated with dynamic ECG changes and or raised troponin levels

  3. Heart failure

  4. Stroke

  5. Hypoglycaemia (RBG < 70 mg/dL or 3.9 mmol/L)

  6. Weight change (5% weight loss or gain over three months)

[

Monthly after discharge for 3 months

]

Target number/sample size

330

Countries of recruitment

Sri Lanka

Anticipated start date

2014-10-07

Anticipated end date

2015-10-07

Date of first enrollment

2014-11-07

Date of study completion

Recruitment status

Recruiting

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-08-21

Approval number

EC-14-098

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Lalana Devi Ranasinghe
Senior Registrar in Endocrinology
Diabetic and Endocrine clinic, National Hospital of Sri Lanka, Colombo 10.

0718191302

lalana.devi@gmail.com

Contact Person for Public Queries

Dr. Noel Somasundaram
Consultant Endocrinologist
Diabetic and Endocrine clinic, National Hospital of Sri Lanka, Colombo 10.

0776029924

noelsomasundaram@gmail.com

Primary study sponsor/organization

National Hospital of Sri Lanka

Colombo 10, Sri Lanka
Tel: +9411-2691111
Fax: +9411-2698443

http://www.nationalhospital.lk/index.php

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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