Oral Therapy for New-Onset Type 2 Diabetic Patients with Severe Hyperglycemia

Summary and Comment |
June 23, 2016

Oral Therapy for New-Onset Type 2 Diabetic Patients with Severe Hyperglycemia

  1. Allan S. Brett, MD

Two oral regimens were effective in patients with blood glucose levels between 300 and 450 mg/dL.

  1. Allan S. Brett, MD

An American Diabetes Association guideline (Diabetes Care 2016; 39 [Suppl 1]:1) recommends insulin therapy for most patients with type 2 diabetes who present initially with severe hyperglycemia (i.e., blood glucose level, ≥300 mg/dL); however, oral regimens also can be effective. In this study, researchers enrolled 100 adults with newly diagnosed type 2 diabetes, glucose levels of 300 to 450 mg/dL, and no evidence of ketoacidosis or hyperosmolar symptoms. Patients were randomized to receive one daily dose of either extended-release glipizide (10 mg) or a fixed combination of 5-mg saxagliptin plus 2000-mg metformin (Kombiglyze XR). The study was funded by the maker of Kombiglyze.

At initial diagnosis, mean glucose level was 342 mg/dL, and mean glycosylated hemoglobin (HbA1c) was 11%. All patients received diabetes education and had close follow-up at a diabetes center. At 12 weeks, glycemic control improved substantially in nearly all patients in both groups (mean blood glucose level, about 130 mg/dL; mean HbA1c, about 7%). Prevalence of hypoglycemia (glucose level, <70 mg/dL) was greater with glipizide than with saxagliptin/metformin (24% vs. 8%), but severe hypoglycemia (<50 mg/dL) did not occur in either group.

Comment

Oral therapy is an acceptable option for clinically stable, newly diagnosed type 2 diabetic patients with blood glucose levels between 300 and 450 mg/dL. Regimens can be adjusted during follow-up, depending on patients' glycemic response to initial treatment and the extent to which they modify diet and physical activity. The take-home message should not be that Kombiglyze (cash price, about US$5,000 annually) is the drug of choice; for selected motivated patients, I have even used metformin monotherapy successfully in this setting.

Editor Disclosures at Time of Publication

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose

Citation(s):

Reader Comments (8)

Botta de Assis, AC Physician, Endocrinology, San Francisco University, Bragança Paulista, Brasil

I interpret the ADA guideline for the use of insulin therapy for most patients with type 2 diabetes who present initially with severe hyperglycemia as the use of regular insulin until is reached the control of glycemia with associated oral drugs, diet and physical activity. I don't use NPH insulin as first option in initial threatment of these patients. Usually these patients will be controled without insulin after some days or weeks.

Raya Almazrouei Fellow-In-Training, Endocrinology, Governmental hospital

This is a very common senario in our practice and most patient will refuse to start insulin. We found very good response with combination therapy of 2 or 3 OHAs. Mainly we use SU with less hypoglycemia risk like gliclazide plus DDP4 inhibitor and metformin. We do not start the full dose of metformin from the beginning , rather we titarte it over 2-3 weeks. Most patients improve dramatically and will remain on two OHAs only. In addition, for those patient who are started on insulin, we start with basal insulin plus combination of DDP4 inhibitor with metformin and usually with good response and insulin can be stopped earlier by this way.

MOHANASUNDARAM THIRUVENKADM, MD Physician, Internal Medicine, Government medical college, OGE , CHENNAI

What is the impact of life style modification on glycemic control. Whether the severity of GI symptoms assessed or not with 2 gm metformin because our patients doesn't tollerate.
Most of the newly diagnosed patients opt for 2/3 drug OAD combination rather than Insulin in our setup and the glycemic control is also good

CAROL VASSAR Physician, Internal Medicine, Private practice

Once again, Allan Brett, MD has written a succinct summary and a reasonable helpful comment. Thank you. Your work is very much appreciated.

LORETTA SERNEKOS Nurse/NP/PA, Family Medicine/General Practice

The scenario described (initial blood glucose > 300, initial A1c approx. 11%) is one that is encountered fairly commonly in primary care. It is reassuring that we can start stable (no DKA/HHS signs) patients on an oral regimen, as many patients will balk at the word "insulin". However, if I start a patient on 2,000 mg metformin (the amount in the Kombiglyze XR regimen used in the study), the GI distress can be significant in many patients. Diarrhea can be bad enough to cause the patient to lose work time and/or discontinue the drug. Therefore, I usually have to titrate metformin over several weeks, which is less desirable if initial blood glucose is very high. Glipizide, as the summary notes, carries a higher risk of hypoglycemia which can be mitigated somewhat by patient teaching (timing of medication vis-a-vis meals, symptoms of hypoglycemia, etc.). But in patients who experience significant GI distress, glipizide might result in better adherence to the medication regimen.

H ROBERT SILVESTEIN Physician, Cardiology, Preventive Medicine Center

Very useful. Breakthru study: beneficial transformative innovation

renzo cordera Physician, Endocrinology, university of Genova

this paper confirms the non superiority of incretins on sulfonylureas as drug of choice for most of Patients with T2DM. if not superior the cost of a treatment should be taken into account for a tailored treatment. we discussed these items in the following comments:
1) the economic burden of severe hypoglycemia: Two sides of the same coin. Gallo F, Maggi D, Cordera R.
Nutr Metab Cardiovasc Dis. 2016
2) Comment on Inzucchi et al. Management of Hyperglycemia in.. ...Mazzucchelli C, Bordone C, Maggi D, Cordera R.
Diabetes Care. 2015 :8, e 125-126

Sanford C. Barnes, MD Physician, Dermatology, Retired from Univ. of Wash. Sch. of Med.

What other outcomes, other than blood glucose control, are affected? What are the short or long term risks of the medications?

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