Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, we aim to explore the beneficial effect of early short-term (two weeks), self-titrated, basal-only insulin therapy on the degree of glycemic control over 1-year follow through a prospective cohort.
Despite the development of new drugs and therapeutic strategies for treating type 2 diabetes mellitus (T2DM), achieving long-term glycemic control remains a challenge. Results from the United Kingdom Prospective Diabetes Study (UKPDS) suggest that deterioration of glycemic control can be largely attributed to progressive β-cell loss, irrespective of the nature of pharmacological intervention. Therefore, treatments that can preserve or improve β-cell function are of great interest in the field of T2DM therapeutics. Some studies have shown that short-term intensive insulin therapy in patients newly diagnosed with T2DM produces beneficial effects on β-cell function, glycemic control, and rate of remission within 1 year. However, these studies applied complex regimes for insulin initiations that require frequent follow-up and are difficult to accept as initial therapy for T2DM.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| basal insulin plus glucose lowering drugs | Active Comparator | New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl. Agree to start basal insulin for two weeks |
|
| glucose lowering drugs only | Active Comparator | New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl. Refuse to start basal insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine 100 UNT/ML Pen Injector [Lantus] | Drug | Insulin is given as glargine U100 at bedtime in a dose of 10 units. The patients will be given instruction to up-titrate the insulin by adding two units every two days with an aim to reach fasting blood glucose (FBG) between 80 - 130 mg/dl using a home glucometer. And to down-titrate the insulin by subtracting two units when the FBG is below 80 mg/dl. The patients continued on basal insulin for two weeks or less when FBG is persistently below 100 mg/dl on a dose of 10 units of insulin Glargine. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | three months |
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | six months |
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | twelve months |
| Change in hemoglobin A1c | mean change in hemoglobin A1c | three months |
| Change in hemoglobin A1c | mean change in hemoglobin A1c | six months |
| Change in hemoglobin A1c | mean change in hemoglobin A1c | twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer. | two weeks |
Not provided
Inclusion Criteria: (must have)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Haider A Alidrisi, MD | Faiha Specialized Diabetes, Endocrine, and Metabolism Center, University of Basrah, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faiha Specialized Diabetes, Endocrine, and Metabolism Center | Basra | 61001 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18502299 | Background | 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. | |
| 9283777 |
Not provided
Not provided
It is not yet known if there will be a plan to make IPD available.
Not provided
Not provided
Not provided
Not provided
Not provided
Inclusion criteria:
The study will compare the effect of two strategies for glucose control over one year. First, two-week basal insulin and combination glucose-lowering drugs. Second, combination glucose-lowering drugs
Not provided
Not provided
Not provided
Not provided
|
|
| Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg | Drug | Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg |
|
|
| Pioglitazone 30mg | Drug | Pioglitazone 30mg |
|
|
| Background |
| Ilkova H, Glaser B, Tunckale A, Bagriacik N, Cerasi E. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients by transient intensive insulin treatment. Diabetes Care. 1997 Sep;20(9):1353-6. doi: 10.2337/diacare.20.9.1353. |
| 15504992 | Background | 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. |
| 15111515 | Background | Ryan EA, Imes S, Wallace C. Short-term intensive insulin therapy in newly diagnosed type 2 diabetes. Diabetes Care. 2004 May;27(5):1028-32. doi: 10.2337/diacare.27.5.1028. |
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C502994 | saxagliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided