Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00965406 |
Recruitment Status
:
Completed
First Posted
: August 25, 2009
Last Update Posted
: May 2, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Drug: GIK and intensive insulin therapy | Phase 3 |
It is well recognised that diabetes is a factor of worse prognosis in acute coronary syndrome (ACS). Recently, the relationship between the glucidic metabolism and cardiac ischemia was highlighted whether patients have diabetes or not. Indeed, it was established that hyperglycemia occurring during hospitalization in non diabetic patients, is a powerful risk factor of death.
Stress related hyperglycemia occurs during number of acute pathological situations (AMI, stroke, pancreatitis, hypothermia, hypoxia, cirrhosis, polytrauma, burn, sepsis…. It is due to an excess of hyperglycemia hormones (glucagon, growth hormone, catecholamines and glucosteroids) and of inflammatory mediators (cytokines…). Hyperglycemia has several deleterious effects on the cardiovascular system as it promotes microvascular inflammatory reaction, activation of the coagulation system, and free radical oxygen liberation.
Currently, the idea of controlling glycemia in surgical and medical intensive care patients is widely accepted and maintaining blood sugar level closest to normal by intensive insulin therapy became largely recommended.
Several decades ago, glucose-insulin-potassium infusion (GIK) was proposed to protect acute cardiac ischemia. GIK has been assessed in many previous studies.
The results of these studies are contradictory. According to CREATE-ECLA study which is the largest (including 20201 patients), GIK didn't show a significant beneficial effect in ACS. However, in these trials using GIK alone glycemia was not strictly controlled.
Recently, the importance of tight glycemic control has been highlighted in ICU patients and early post heart surgery. Our hypothesis is that GIK treatment associated to intensive insulin therapy in ACS would be beneficial and superior to GIK alone possibly because intensive insulin therapy would prevent potential deleterious effects of hyperglycemia induced by GIK.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 772 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone in the Early Management of Acute Coronary Syndrome: Randomised Controlled Study |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: glucose insulin potassium (GIK)
Glucose + insulin +6 potassium (GIK) infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours.
|
Drug: GIK and intensive insulin therapy
GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours. Intravenous intensive insulin therapy is simultaneously administered according to our protocol in the ED
Other Name: GIKI2
|
Experimental: GIK and intensive insulin therapy
GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours. Intravenous intensive insulin therapy is simultaneously administered according to our protocol in the ED
|
Drug: GIK and intensive insulin therapy
GIK infusion (1000 ml of Glucose 10%, 20 UI Insulin, 70 mEq of Potassium) within 24 hours. Intravenous intensive insulin therapy is simultaneously administered according to our protocol in the ED
Other Name: GIKI2
|
No Intervention: Control group
No intervention and patients were treated with updated international recommendations of acute coronary syndrome.
|
- 30 days mortality, reinfarction, urgent coronary revascularisation, and stroke. [ Time Frame: 24 hours ]
- Severe dysrhythmias, acute left ventricular failure with ejection fraction<45%, serum troponin, PAI level and platelet factor activator (PFA-100) within 24 hours after the start of protocol treatment. Safety: major or minor hypoglycemia [ Time Frame: 24 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients fulfilling ACS criteria with or without known diabetes.
Exclusion Criteria:
- Patients under 18 years old.
- Killip II class or SaO2 ≤ 90%.
- Blood creatinine ≥ 180 µmol/L
- Potassium serum ≥ 6.5 mmol/L.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965406
Tunisia | |
Mahdia University Hospital | |
Monastir, Mahdia, Tunisia | |
Monastir University Hospital | |
Monastir, Tunisia, 5000 | |
Sahloul University Hospital | |
Sousse, Tunisia |
Principal Investigator: | nouira semir, Prof. | Research Laboratory (LR12SP18) University of Monastir Tunisia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pr. Semir Nouira, Prof. Semir Nouira, University of Monastir |
ClinicalTrials.gov Identifier: | NCT00965406 History of Changes |
Other Study ID Numbers: |
GIKI2 |
First Posted: | August 25, 2009 Key Record Dates |
Last Update Posted: | May 2, 2017 |
Last Verified: | April 2017 |
Keywords provided by Pr. Semir Nouira, University of Monastir:
acute coronary syndrome glucose insulin potassium |
Additional relevant MeSH terms:
Syndrome Acute Coronary Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |