Characteristics of pregnant women with diabetes using injectable glucose-lowering drugs in the EVOLVE study.

Aims: To examine clinical parameters, glycemic control, folic acid supplementation, and the presence of other chronic diseases during early pregnancy in the EVOLVE study population (women with pre-existing diabetes treated with injectable glucose-lowering drugs).

Methods: Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16.

Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study.

Aims: To compare the effects of continuing versus discontinuing sitagliptin when initiating and intensively titrating insulin glargine.

Materials And Methods: Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500 mg/d) in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sulphonylurea. Those on metformin + sitagliptin were directly randomized; all others were switched to metformin + sitagliptin (discontinuing other DPP-4 inhibitors and sulphonylureas) and stabilized during a run-in period.

Relationship of body mass index with efficacy of exenatide twice daily added to insulin glargine in patients with type 2 diabetes.

This post hoc analysis assessed the evidence behind common reimbursement practices by evaluating the relationship of body mass index (BMI) ranges (<30, 30-35 and >35 kg/m(2) ) with treatment effects of exenatide twice daily among patients with type 2 diabetes. Patients received exenatide twice daily added to insulin glargine in two 30-week studies (exenatide twice daily vs insulin lispro, n = 627; exenatide twice daily vs placebo, n = 259). No association of baseline BMI with changes in efficacy variables was observed.

Efficacy and safety of linagliptin as add-on therapy to basal insulin and metformin in people with Type 2 diabetes.

Aim: To evaluate the efficacy and safety of linagliptin in people with Type 2 diabetes inadequately controlled on basal insulin and metformin.

Methods: This was a post hoc subanalysis of participants who received basal insulin and metformin in a global phase III study that randomized participants (1:1) to receive linagliptin 5 mg once daily or placebo for ≥52 weeks as add-on therapy to basal insulin alone or in combination with metformin and/or pioglitazone. During the first 24 weeks, the background dose of basal insulin remained stable; thereafter, adjustments based on glucose concentrations were recommended.

Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION).

Aims: To assess the efficacy and safety of adjunctive saxagliptin vs glimepiride in elderly patients with type 2 diabetes (T2D) and inadequate glycaemic control.

Methods: In this multinational, randomized, double-blind, phase IIIb/IV study (GENERATION; NCT01006603), patients aged ≥65 years were randomized (1 : 1) to receive saxagliptin 5 mg/day or glimepiride ≤6 mg/day, added to metformin, during a 52-week treatment period. The primary endpoint was achievement of glycated haemoglobin (HbA1c) <7.

Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data.

Aims: To assess the long-term efficacy and tolerability of dapagliflozin versus glipizide as add-on to metformin in patients with inadequately controlled type 2 diabetes.

Methods: The present study was an extension of an earlier randomized, double-blind, phase III study of dapagliflozin (n = 406) vs glipizide (n = 408) to 208 weeks (4 years). Patients continued to receive their assigned medication.

Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.

Aims: To assess the long-term glycaemic durability, safety and tolerability of dapagliflozin versus glipizide as add-on therapies in patients with type 2 diabetes inadequately controlled by metformin alone.

Methods: This was a 52-week, randomised, double-blind study of dapagliflozin (n = 406) versus glipizide (n = 408), uptitrated over 18 weeks according to tolerability and glycaemic response to a maximum of 10 and 20 mg/day, respectively, as add-on therapies to metformin (≥ 1500 mg/day) with a 156-week double-blind extension period. Data over 104 weeks are reported here.

Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a ≥52-week randomized, double-blind study.

Objective: To evaluate the efficacy and long-term safety of linagliptin added to basal insulins in type 2 diabetes inadequately controlled on basal insulin with or without oral agents.

Research Design And Methods: A total of 1,261 patients (HbA1c ≥7.0% [53 mmol/mol] to ≤10.

A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes.

Objective: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented.

Methods: Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks.

[Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin].

Objective: Although initially effective, sulfonylureas are associated with poor glycemic durability, weight gain, and hypoglycemia. Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycemia by increasing urinary glucose excretion independent of insulin and may cause fewer of these adverse effects. We compared the efficacy, safety, and tolerability of dapagliflozin with the sulfonylurea glipizide in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes.

Objective: This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes.

Research Design And Methods: Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.

Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial.

Objective: Although initially effective, sulfonylureas are associated with poor glycemic durability, weight gain, and hypoglycemia. Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycemia by increasing urinary glucose excretion independent of insulin and may cause fewer of these adverse effects. We compared the efficacy, safety, and tolerability of dapagliflozin with the sulfonylurea glipizide in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

[Usefulness of genetic tests in familial hypocalciuric hypercalcemia with atypical clinical presentation].

Objectives: Biochemical tests related to calcium and phosphorus metabolism have traditionally been considered as a reliable tool to differentiate familial hypocalciuric hypercalcemia (FHH) from primary hyperparathyroidism (PHPT). However, diagnosis may sometimes be difficult even for experienced clinicians. Our objective was to assess the accuracy of diagnostic tests in FHH and the circumstances in which genetic studies are required.

Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study.

OBJECTIVE A recent randomized trial compared prandial insulin aspart (IAsp) with human insulin in type 1 diabetic pregnancy. The aim of this exploratory analysis was to investigate the incidence of severe hypoglycemia during pregnancy and compare women enrolled preconception with women enrolled during early pregnancy. RESEARCH DESIGN AND METHODS IAsp administered immediately before each meal was compared with human insulin administered 30 min before each meal in 99 subjects (44 to IAsp and 55 to human insulin) randomly assigned preconception and in 223 subjects (113 for IAsp and 110 for human insulin) randomly assigned in early pregnancy (<10 weeks).

Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus.

Objective: To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2).

Material And Methods: We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients,the following information was available before starting insulin treatment: HbA(1c) levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week.

The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial.

Background: Exenatide therapy is effective in combination with metformin or sulfonylureas for treating type 2 diabetes. Thiazolidinediones (TZDs) also are commonly used, but the efficacy of exenatide with a TZD has not been reported.

Objective: To compare the effects of exenatide versus placebo on glycemic control.

[Pioglitazone. Review of its metabolic and systemic effects].

Type 2 diabetes mellitus has become a true epidemic and significant growth is expected in the next decades. Thus it could be expected that the impact it may have on the incidence and prevalence of cardiovascular morbidity-mortality will have considerable magnitudes. It has been demonstrated that adequate metabolic control (glycemic and lipid) of these patients, beginning with diet and exercise programs and then with drug measures, decreases the risk of complications.

[A glucose tolerance study in the 12 months postpartum in patients with gestational diabetes].

Background: It has been reported that patients with gestational diabetes have a considerable long term risk of developing diabetes mellitus.

Method: Glucose tolerance was studied in the 12 months following birth in 155 patients diagnosed by the authors as having gestational diabetes and followed during pregnancy.

Results: It was observed that in 48% of the patients alterations persisted (33% glucose intolerance and 15% diabetes mellitus).

[The dawn phenomenon in diabetic pregnancy].

The possible development of the dawn phenomenon in three gestational stages was investigated in 9 pregnant women with type I diabetes mellitus and 10 with gestational diabetes. To this end, the overnight intravenous insulin infusion was evaluated with the artificial pancreas (Biostator). In none of the two clinical conditions and in none of the three gestational stages an increased insulin infusions during the second period of the night was found under the experimental conditions of our study.

[Evaluation of diabetes knowledge in patients with insulin-dependent diabetes mellitus. Influential factors and analysis of its relation with blood glucose control].

The level of diabetes education has been evaluated by means of a test questionnaire with 62 items in a group of 57 insulin-dependent Diabetes Mellitus (type I) patients who were cared for at a Hospital Diabetes Unit for a least six months prior the study. We observed that only 60% of our patients had an acceptable diabetes education. Our educational programme seems to be efficient for patients between 20 and 40 years old with a High School or University degree, although we think that the educational method should be changed for older or less educated patients.

[Evaluation of the insulin requirements with an artificial pancreas in gestational diabetes].

The evolution of insulin requirements in 10 patients with gestational diabetes mellitus was evaluated with the use of an artificial pancreas. We found that intravenous insulin requirements showed a definite tendency to decline, the greatest reduction being found between gestational weeks 27 and 37. Postprandial requirements after lunch were significantly higher in the weeks 15 and 27, with a tendency to become equal to those corresponding to breakfast and dinner in week 37.

[Evaluation of the insulin requirements with an artificial pancreas in the pregnant woman with gestational insulin-dependent diabetes (type I)].

The evolution of insulin requirements in 9 pregnant women with insulin-dependent diabetes mellitus (type I) was evaluated. Requirements were increased between weeks 11 and 24 and remained stable between weeks 24 and 35. Those corresponding to breakfast in the two initial connections were significantly higher, while those corresponding to breakfast, lunch and dinner became equal in the last connection (35 gestational weeks).