Early Insulin Glargine Initiation in Iranian People With Uncontrolled Type 2 Diabetes: Glycemic Control, and Adverse Events

  • Mohammad Ebrahim Khamseh Mail Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
  • Alireza Esteghamati Endocrinology and Metabolism Research Center (EMRC), Vali-e-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.
  • Mitra Niafar Department of Endocrinology and Metabolism, Tabriz University of Medical Sciences, Tabriz, Iran.
  • Davoud Abbasi Department of Medicine, Iran Diabetes Association, Islamshahr, Iran.
  • Manouchehr Mohamad Beiki Department of Endocrinology, Prevention of Metabolic Disorder, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Long-acting insulin, Adverse effects, Hyperglycemia, Hypoglycemia


To explore glycemic control, and adverse events of Iranian people with uncontrolled type 2 diabetes after initiation of long-acting basal insulin, glargine. People with uncontrolled type 2 diabetes that was on at least two oral anti-diabetic drugs (OAD) were enrolled in this observational prospective study. Insulin glargine was prescribed by physicians in the course of routine clinical practice. Patients were followed for 24 weeks. Insulin doses were titrated to reach fasting blood sugar (FBS) target between 90 mg/dl and 130 mg/dl. HbA1c and adverse events were recorded at baseline, week 12, and week 24. Form a total of 292 participants, 243 patients completed the study. HbA1c, FBS, postprandial glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol, but not body mass index decreased during the study. The proportion of poorly controlled patients (HbA1C>9%) decreased from 172 (58.9%) to 39(13.4%), and 21(7.2%) during follow up. Controlled glycemia (HbA1C<7%) was detected in 7(2.4%), 48 (16.4%) and 56 (19.2%) of patients at baseline, week 12 and week 24. Hypoglycemia was reported in 5.1% and 3.4% of the participants in the week at 12 and 24, respectively. Patients felt more satisfied with their blood glucose control, timing and choices of meals, and hypo/hyperglycemic experiences. Insulin glargine initiation in people with uncontrolled type 2 diabetes on 2 OADs is associated with significant improvement in metabolic control.  Insulin glargine has good safety profile and well tolerated by the patients.


International Diabetes Federation. IDF Diabetes Atlas 7th Edition. (Accessed January 2018, 12, at https://www.idf.org/e-library/epidemiology-research/dia-betes-atlas.html).

Esteghamati A, Khalilzadeh O, Mohammad K, Meysamie A, Rashidi A, Kamgar M, et al. Secular trends of obesity in Iran between 1999 and 2007: National Surveys of Risk Factors of Non-communicable Diseases. Metab Syndr Relat Disord 2010;8:209-13.

Esteghamati A, Khalilzadeh O, Rashidi A, Kamgar M, Meysamie A, Abbasi M. Physical activity in Iran: results of the third national surveillance of risk factors of non-communicable diseases (SuRFNCD2007). J Phys Activ Health 2011;8:27-35.

Esteghamati A, Noshad S, Nazeri A, Khalilzadeh O, Khalili M, Nakhjavani M. Patterns of fruit and vegetable consumption among Iranian adults: a SuRFNCD-2007 study. Br J Nutr 2012;108:177-81.

Esteghamati A, Abbasi M, Alikhani S, Gouya MM, Delavari A, Shishehbor MH, et al. Prevalence, awareness, treatment, and risk factors associated with hypertension in the Iranian population: the national survey of risk factors for noncommunicable diseases of Iran. Am J Hypertens 2008;21:620-6.

Esteghamati A, Khalilzadeh O, Anvari M, Meysamie A,Abbasi M, Forouzanfar M, et al. The economic costs of diabetes: a populationbased study in Tehran, Iran. Diabetologia 2009;52:1520-7.

Stratton IM, Adler AI, Neil HAW, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12.

Saaddine JB, Cadwell B, Gregg EW, Engelgau MM, Vinicor F, Imperatore G, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988–2002. Ann Intern Med 2006;144:465-74.

Group UPDS. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53.

Ghazanfari Z, Niknami S, Ghofranipour F, Larijani B, AghaAlinejad H, Montazeri A. Determinants of glycemic control in female diabetic patients: a study from Iran. Lipid Health Dis 2010;9:83.

Karter AJ, Moffet HH, Liu J, Parker MM, Ahmed AT, Ferrara A, et al. Achieving good glycemic control: initiation of new antihyperglycemic therapies in patients with type 2 diabetes from the Kaiser Permanente Northern California Diabetes Registry. Am J Manag Care 2005;11:262-70.

Zhang S, Chen Z, Yan L, Chen L, Cheng H, Ji L. Determinants for inadequate glycaemic control in Chinese patients with mildtomoderate type 2 diabetes on oral antidiabetic drugs alone. Chinese Med J 2011;124:2461-8.

Mirzazadeh A, Baradaran HR, Haghdoost AA, Salari P. Related factors to disparity of diabetes care in Iran. Med Sci Monit 2009;15:PH32-6.

Lebovitz HE. Type 2 diabetes: an overview. Clin Chem 1999;45:1339-45.

Blicklé JF, Hancu N, Piletic M, Profozic V, Shestakova M, Dain MP, et al. Insulin glargine provides greater improvements in glycaemic control vs. intensifying lifestyle management for people with type 2 diabetes treated with OADs and 7–8% A1c levels. The TULIP study. Diabetes Obes Metab 2009;11:379-86.

Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193-203.

Kumar A. Early use of insulin for beta cell preservation. J Assoc Physicians India 2007;55:26.

Monnier L, Colette C, Mas E, Michel F, Cristol J,Boegner C, et al. Regulation of oxidative stress by glycaemic control: evidence for an independent inhibitory effect of insulin therapy. Diabetologia 2010;53:562-71.

Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes 2002;26:S18-24.

Cryer P. Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia 2002;45:937-48.

Davies M, Evans R, Storms F, Gomis R, Khunti K. Initiation of insulin glargine in suboptimally controlled patients with type 2 diabetes: sub‐analysis of the AT. LANTUS trial comparing treatment outcomes in subjects from primary and secondary care in the UK. Diabetes Obes Metab 2007;9:706-13.

Fritsche A, Schweitzer MA, Ha-ring H-U. Glimepiride Combined with Morning Insulin Glargine, Bedtime Neutral Protamine Hagedorn Insulin, or Bedtime Insulin Glargine in Patients with Type 2 DiabetesA Randomized, Controlled Trial. Ann Intern Med 2003;138:952-9.

Pfeiffer C, Winkler F, Luger A, Pieber T, Saudek F, Skrha J, et al. Safety and efficacy of insulin glargine (HOE 901) versus NPH insulin in combination with oral treatment in Type 2 diabetic patients. Diabetic Med 2003;20:545-51.

Rosenstock J, Schwartz SL, Clark CM, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes. Diabetes Care 2001;24:631-6.

Fonseca V, Bell DS, Berger S, Thomson S, Mecca TE. A comparison of bedtime insulin glargine with bedtime neutral protamine hagedorn insulin in patients with type 2 diabetes: subgroup analysis of patients taking once-daily insulin in a multicenter, randomized, parallel group study. Am J Med Sci 2004;328:274-80.

Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, Vähätalo M, Virtamo H, Nikkilä K, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49:442-51.

Yki-Järvinen H, Dressler A, Ziemen M, Group HsS. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 2000;23:1130-6.

Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26:3080-6.

Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A,

Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine. Diabetes Care 2005;28:950-5.

Benedetti MM, Humburg E, Dressler A, Ziemen M, Group S. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res 2003;35:189-96.

Campbell RK, White JR. Insulin therapy in type 2 diabetes. J Am Pharm Assoc 2002;42:602-11.

Garces K. Insulin glargine: a long-acting insulin for diabetes mellitus. Issues Emerg Health Technol 2003;52:1-4.

Gerich JE. Insulin glargine: long-acting basal insulin analog for improved metabolic control. Current medical Res Opin 2004;20:31-7.

Stammberger I, Bube A, Durchfeld-Meyer B, Donaubauer H, Troschau G. Evaluation of the carcinogenic potential of insulin glargine (LANTUS) in rats and mice. Int J Toxicol 2002;21:171-9.

Hathout EH, Fujishige L, Geach J, Ischandar M, Maruo S, Mace JW. Effect of therapy with insulin glargine (Lantus®) on glycemic control in toddlers, children, and adolescents with diabetes. Diabetes Technol Ther 2003;5:801-6.

Scholtz H, Pretorius S, Wessels D, Venter C, Potgieter M, Becker R. Equipotency of insulin glargine and regular human insulin on glucose disposal in healthy subjects following intravenous infusion. Acta Diabetologica 2003;40:156-62.

Vehkavaara S, Yki-Järvinen H. 3.5 years of insulin therapy with insulin glargine improves in vivo endothelial function in type 2 diabetes. Arterioscler Thromb Vasc Biol 2004;24:325-30.

Westerbacka J, Bergholm R, Tiikkainen M, Yki-Järvinen H. Glargine and regular human insulin similarly acutely enhance endothelium-dependent vasodilatation in normal subjects. Arterioscler Thromb Vasc Biol 2004;24:320-4.

Vajo Z, Duckworth W. Advances in the treatment of diabetes-insulin analogues. Minerva Endocrinol 2002;27:167-80.

Lindholm A. New insulins in the treatment of diabetes mellitus. Best Pract Res Clin Gastroenterol 2002;16:475-92.

Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. US Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care 2000;23:639-43

How to Cite
Khamseh ME, Esteghamati A, Niafar M, Abbasi D, Mohamad Beiki M. Early Insulin Glargine Initiation in Iranian People With Uncontrolled Type 2 Diabetes: Glycemic Control, and Adverse Events. Acta Med Iran. 56(4):249-254.